Heartware, Inc.: Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

Recall number

Z-2056-2020

Recalling firm

Heartware, Inc.

Product

Heartware HVAD Pump Implant Kit, Product (REF) Number 1104

Status

Open, Classified

Initiated

2020-04-03

Posted

not on file

Terminated

not on file

Reason

The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.

Root cause

Device Design

Action

The firm disseminated a Medical Device Safety Alert by letter beginning on 04/03/2020. The notice explained he potential for damage that can occur during the procedure. Specifically, the Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump. The letter also provided additional steps for assembly and attachment to reduce the risk of damage and tearing during the assembly procedure which was provided in Appendix A.

Quantity

2225 Units

Distribution

Worldwide Distribution

Lot, serial or model codes

GTIN 00888707002028, Serial Numbers: HW28848, hw29011, HW29154, HW29211, HW29248, HW29249, HW29273, HW29329, HW29426, HW29465, HW29472, HW29522, HW29534, HW29548, HW29549, HW29567, HW29588, HW29593, HW29602, HW29612, HW29667, HW29700, HW29786, HW29815, HW29915, HW29928, HW29949, HW30039, HW30082, HW30083, HW30150, HW30153, HW30208, HW30211, HW30226, HW30320, HW30342, HW30358, HW30360, HW30363, HW30378, HW30380, HW30382, HW30390, HW30398, HW30400, HW30402, HW30406, HW30410, HW30430, HW30475, HW30484, HW30494, HW30498, HW30595, HW30596, HW30597, HW30601, HW30604, HW30651, HW30768, HW30769, HW30770, HW30771, HW30814, HW30821, HW30829, HW30863, HW30865, HW30867, HW30871, HW30953, HW30961, HW30962, HW30966, HW30971, HW30972, HW30974, HW31020, HW31076, HW31101, HW31103, HW31104, HW31107, HW31113, HW31115, HW31117, HW31119, HW31128, HW31132, HW31134, HW31192, HW31219, HW31223, HW31232, HW31235, HW31242, HW31244, HW31249, HW31254, HW31255, HW31260, HW31261, HW31262, HW31267, HW31383, HW31387, HW31388, HW31399, HW31409, HW31410, HW31411, HW31412, HW31414, hw31445, HW31446, hw31447, hw31448, hw31449, hw31451, HW31452, hw31453, hw31454, HW31455, HW31456, HW31457, HW31458, HW31541, HW31543, HW31544, HW31545, HW31547, HW31548, HW31549, HW31550, HW31552, HW31559, HW31564, HW31571, HW31573, HW31578, HW31579, HW31686, HW31694, HW31697, HW31731, HW31749, HW31750, HW31777, HW31778, HW31810, HW31819, HW31830, HW31831, HW31832, HW31834, HW31835, HW31836, HW31838, HW31839, HW31840, HW31842, HW31843, HW31844, HW31845, HW31846, HW31847, HW31849, HW31855, HW31858, HW31876, HW31883, HW31944, HW31947, HW31979, HW31981, HW31986, HW31987, HW31988, HW31989, HW31991, HW32068, HW32116, HW32121, HW32141, HW32143, HW32156, HW32159, HW32161, HW32162, HW32164, HW32167, HW32172, HW32179, HW32189, HW32190, HW32192, HW32193, HW32194, HW32197, HW32199, HW32201, HW32204, HW32206, HW32209, HW32210, HW32214, HW32215, HW32216, HW32218, HW32220, HW32222, HW32223, HW32224, HW32228, HW32229, HW32230, HW32231, HW32248, HW32258, HW32259, HW32260, HW32261, HW32273, HW32279, HW32281, HW32285, HW32286, HW32290, HW32292, HW32315, HW32335, HW32357, HW32386, HW32393, HW32400, HW32419, HW32423, HW32426, HW32427, HW32457, HW32458, HW32459, HW32464, HW32465, HW32468, HW32470, HW32471, HW32472, HW32474, HW32479, HW32499, HW32504, HW32508, HW32509, HW32510, HW32511, HW32516, HW32534, HW34001, HW34002, HW34025, HW34034, HW34035, HW34036, HW34037, HW34038, HW34040, HW34041, HW34042, HW34043, HW34044, HW34045, HW34046, HW34047, HW34048, HW34051, HW34066, HW34096, HW34100, HW34104, HW34106, HW34109, HW34110, HW34111, HW34113, HW34117, HW34121, HW34126, HW34151, HW34169, HW34179, HW34181, HW34186, HW34187, HW34192, HW34193, HW34196, HW34197, HW34202, HW34204, HW34205, HW34207, HW34209, HW34211, HW34226, HW34317, HW34319, HW34326, HW34328, HW34329, HW34330, HW34331, HW34336, HW34342, HW34344, HW34347, HW34368, HW34369, HW34371, HW34372, HW34373, HW34375, HW34376, HW34377, HW34378, HW34379, HW34425, HW34427, HW34428, HW34429, HW34432, HW34446, HW34495, HW34519, HW34520, HW34521, HW34522, HW34523, HW34546, HW34547, HW34550, HW34551, HW34555, HW34556, HW34588, HW34590, HW34596, HW34603, HW34605, HW34609, HW34610, HW34643, HW34673, HW34752, HW34768, HW34805, HW34806, HW34808, HW34810, HW34824, HW34840, HW34842, HW34845, HW34866, HW34868, HW34877, HW34902, HW34903, HW34904, HW34908, HW34910, HW34913, HW34914, HW34923, HW34924, HW34925, HW34928, HW34933, HW34934, HW34938, HW34939, HW34944, HW34946, HW34947, HW34948, HW34949, HW34957, HW34979, HW34990, HW34997, HW35012, HW35032, HW35099, HW35122, HW35123, HW35124, HW35125, HW35127, HW35128, HW35131, HW35133, HW35134, HW35136, HW35138, HW35141, HW35142, HW35143, HW35161, HW35189, HW35191, HW35204, HW35205, HW35209, HW35211, HW35212, HW35213, HW35214, HW35215, HW35220, HW35284, HW35305, HW35317, HW35319, HW35321, HW35324, HW35325, HW35326, HW35332, HW35334, HW35337, HW35339, HW35340, HW35341, HW35357, HW35360, HW35361, HW35367, HW35385, HW35464, HW35477, HW35478, HW35479, HW35480, HW35481, HW35482, HW35483, HW35487, HW35488, HW35489, HW35492, HW35493, HW35494, HW35495, HW35499, HW35500, HW35501, HW35502, HW35504, HW35506, HW35508, HW35534, HW35535, HW35539, HW35540, HW35541, HW35542, HW35543, HW35545, HW35548, HW35563, HW35577, HW35578, HW35580, HW35582, HW35583, HW35584, HW35586, HW35587, HW35588, HW35624, HW35625, HW35626, HW35627, HW35628, HW35629, HW35630, HW35631, HW35632, HW35633, HW35634, HW35635, HW35636, HW35637, HW35639, HW35641, HW35644, HW35646, HW35647, HW35668, HW35669, HW35670, HW35671, HW35673, HW35674, HW35676, HW35677, HW35678, HW35680, HW35681, HW35682, HW35683, HW35684, HW35686, HW35687, HW35688, HW35689, HW35690, HW35691, HW35692, HW35693, HW35695, HW35696, HW35697, HW35698, HW35701, HW35702, HW35703, HW35704, HW35705, HW35707, HW35708, HW35730, HW35731 GTIN 00888707002387, Serial Numbers: HW28851, HW29783, HW29793, HW29794, HW29827, HW29870, HW29918, HW30045, HW30046, HW30505, HW30765, HW30842, HW30844, HW30845, HW30846, hw30978, HW31075, HW31077, HW31080, hw31089, hw31091, HW31095, HW31161, HW31342, HW31348, HW31555, HW31556, HW31557, HW31683, HW31860, HW31903, HW31920, HW31924, HW31926, HW32026, HW32027, HW32028, HW32149, HW32153, HW32163, HW32282, HW32513, HW32514, HW32562, HW32563, HW34004, HW34006, HW34091, HW34092, HW34125, HW34272, HW34273, HW34274, HW34349, HW34350, HW34351, HW34352, HW34357, HW34358, HW34359, HW34366, HW34374, HW34436, HW34953, HW34968, HW35080, HW35144, HW35145, HW35148, HW35327, HW35342, HW35344, HW35537, HW35596, HW35603, HW35604, HW35605, HW35606, HW35607, HW35713, HW35714, HW35717, HW35718, HW35721, HW35723 GTIN 00888707001649, Serial Numbers: HW29132, HW29232, hw29653, HW29682, HW29684, HW29705, HW29864, HW29985, HW29991, HW30096, HW30100, HW30145, HW30146, HW30373, HW30374, HW30421, HW30525, HW30529, HW30726, HW30738, HW30836, HW30840, HW30862, HW30939, hw30949, hw30950, HW31048, HW31071, HW31082, HW31088, hw31133, hw31394, HW31415, HW31417, HW31420, HW31421, HW31423, hw31483, hw31505, hw31506, hw31507, hw31510, HW31511, hw31512, hw31513, hw31515, hw31516, hw31517, HW31546, HW31551, HW31554, HW31566, HW31587, HW31588, HW31589, HW31590, HW31592, HW31632, HW31639, HW31685, HW31795, HW31801, HW31806, HW31808, HW31809, HW31811, HW31812, HW31813, HW31815, HW31891, HW31892, HW31893, HW31919, HW31921, HW31973, HW31982, HW31985, HW32000, HW32001, HW32014, HW32015, HW32018, HW32021, HW32022, HW32024, HW32042, HW32050, HW32055, HW32056, HW32064, HW32081, HW32094, HW32112, HW32123, HW32138, HW32147, HW32186, HW32245, HW32255, HW32264, HW32265, HW32268, HW32270, HW32301, HW32394, HW32410, HW32420, HW32558, HW32559, HW32560, HW32561, HW34029, HW34031, HW34093, HW34094, HW34132, HW34148, HW34180, HW34266, HW34268, HW34269, HW34270, HW34271, HW34296, HW34301, HW34324, HW34327, HW34340, HW34341, HW34343, HW34345, HW34346, HW34348, HW34418, HW34420, HW34431, HW34507, HW34508, HW34641, HW34692, HW34745, HW34764, HW34836, HW34906, HW34932, HW34936, HW34940, HW34941, HW34963, HW34977, HW34992, HW34994, HW35019, HW35021, HW35033, HW35035, HW35038, HW35041, HW35065, HW35068, HW35085, HW35090, HW35094, HW35114, HW35147, HW35157, HW35196, HW35197, HW35210, HW35237, HW35250, HW35290, HW35308, HW35309, HW35310, HW35311, HW35312, HW35313, HW35314, HW35315, HW35318, HW35320, HW35328, HW35329, HW35330, HW35333, HW35338, HW35349, HW35365, HW35366, HW35368, HW35370, HW35371, HW35372, HW35373, HW35375, HW35378, HW35402, HW35404, HW35405, HW35408, HW35409, HW35411, HW35412, HW35418, HW35421, HW35423, HW35465, HW35470, HW35475, HW35476, HW35485, HW35486, HW35546, HW35547, HW35550, HW35551, HW35552, HW35553, HW35554, HW35555, HW35556, HW35557, HW35558, HW35559, HW35560, HW35564, HW35598, HW35599, HW35602, HW35640, HW35657, HW35658, HW35659, HW35662, HW35663, HW35664, HW35665, HW35666, HW35667, HW35672, HW35694, HW35719, HW35750, HW35753, HW36121, HW36154, HW36165, HW36168 GTIN 00888707000581, Serial Numbers: HW29203, HW29425, HW29427, HW29428.HW29430, HW29439, HW29517, HW29679, HW29680, HW30589, HW30638, HW30706, HW30876, HW31144, HW31187, hw31376, hw31380, HW31442, HW31727, HW31998, HW32023, HW32416, HW34017 GTIN 00888707002417, Serial Numbers: HW29478, HW30381, HW30831, HW34380, HW34421, HW35348, HW35613, HW35756, HW35761, HW35763  GTIN 00888707002493, Serial Numbers: HW29483, HW29697, HW29698, hw31178, HW31520, HW31821, HW31823, HW31827, HW32086, HW32242, HW32246, HW32518, HW32519, HW34021, HW34365, HW34367, HW34792, HW34915, HW35155, HW35158, HW35252, HW35343, HW35345, HW35346, HW35350, HW35400, HW35401, HW35529, HW35530, HW35574, HW35591, HW35660, HW35661, HW35785 GTIN 00888707002400, Serial Numbers: HW29518, HW29693, HW30092, HW32257, HW34012, HW34210, HW35034, HW35154, HW35573, HW35653 GTIN 00888707002547, Serial Numbers: HW29561, HW29601, HW29931, HW30502, HW30593, HW30619, HW30632, HW30783, HW30796, HW30819, HW30826, HW31136, HW31140, HW31141, HW31156, HW31157, HW31158, HW31382, HW31393, HW31406, HW31408, HW31413, HW31416, HW31426, HW31429, HW31553, HW31791, HW31937, HW31994, HW32118, HW32269, HW32309, HW32336, HW32347, HW32373, HW32385, HW32522, HW32523, HW32524, HW32554, HW32557, HW34003, HW34007, HW34008, HW34049, HW34050, HW34053, HW34054, HW34382, HW34383, HW34513, HW34514, HW34516, HW34517, HW34518, HW35251, HW35275 GTIN 00888707000680, Serial Numbers: HW29571, HW29578, HW29845, HW30635, HW30639, HW30711, HW31150 GTIN 00888707002394, Serial Numbers: HW30469, HW30506, HW30508, HW30509, HW30510, HW30511, HW30512, HW30655, HW31580, HW31582, HW31583, HW31584, HW31992, HW31993, HW32200, HW32207, HW32217, HW32238, HW32239, HW32240, HW32515, HW32517, HW34022, HW34023, HW34395, HW34461, HW34557, HW34561, HW34582, HW34751, HW34950, HW34955, HW34991, HW34996, HW35016, HW35149, HW35150, HW35186, HW35336, HW35386, HW35397, HW35484, HW35509, HW35510, HW35538, HW35566, HW35609, HW35610, HW35611, HW35648, HW35649, HW35651, HW35679, HW35699, HW35700, HW35706, HW35776, HW35779 GTIN 00888707000239, Serial Numbers: HW30634, HW30645, HW30877, HW34737 GTIN 00888707002530, Serial Numbers: HW30797, HW31108, HW31440, HW31828, HW31928, HW32182, HW32253, HW32263, HW34559, HW35000, HW35162, HW35532, HW35533, HW35590  GTIN 00888707002523, Serial Numbers: HW30859, HW31703, HW31704, HW31859, HW32030, HW32036, HW32040, HW32102, HW32520, HW32521, HW34018, HW34020, HW34027, HW34028, HW34986, HW35040, HW35043, HW35049, HW35216, HW35217, HW35218, HW35490, HW35531, HW35619, HW35786 GTIN 00888707002431, Serial Numbers: hw30979, hw31123, HW32029, HW32180, HW34024, HW34381, HW34615, HW35119, HW35733 GTIN 00888707002585, Serial Numbers: hw31079, hw31081, hw31168, hw31170, HW35095, HW35164, HW35351, HW35353, HW35355, HW35496, HW35497, HW35575, HW35576  GTIN 00888707002516, Serial Numbers: hw31147, hw31162, HW32507, HW34524, HW35474 GTIN 00888707006330, Serial Numbers: HW31419, HW31699, HW31733, HW32505, HW35393, HW35396, HW35726, HW35749, HW35766, HW35769, HW35784, HW35829, HW35872, HW36005, HW36007, HW36008, HW36009, HW36010, HW36013, HW36014, HW36015, HW36018, HW36019, HW36020, HW36021, HW36067, HW36068, HW36069, HW36070, HW36071, HW36131, HW36132, HW36138, HW36174, HW36175, HW36176, HW36177, HW36178, HW36179, HW36180, HW36182, HW36184, HW36185, HW36186, HW36192, HW36193, HW36194, HW36195, HW36196, HW36197, HW36198, HW36199, HW36200, HW36201, HW36224, HW36225, HW36226, HW36227, HW36228, HW36229, HW36230, HW36231, HW36232, HW36233, HW36248, HW36249, HW36251, HW36252, HW36253, HW36254, HW36255, HW36256, HW36258, HW36259, HW36260, HW36276, HW36298, HW36299, HW36300, HW36303, HW36305, HW36306, HW36307, HW36309, HW36310, HW36313, HW36314, HW36316, HW36317, HW36318, HW36319, HW36320, HW36321, HW36323, HW36324, HW36325, HW36326, HW36328, HW36332, HW36333, HW36334, HW36335, HW36337, HW36354, HW36355, HW36356, HW36357, HW36358, HW36359, HW36360, HW36361, HW36362, HW36363, HW36396, HW36397, HW36398, HW36399, HW36400, HW36401, HW36403, HW36404, HW36405, HW36406, HW36407, HW36408, HW36409, HW36410, HW36411, HW36412, HW36419, HW36420, HW36428, HW36429, HW36430, HW36432, HW36433, HW36434, HW36435, HW36436, HW36437, HW36438, HW36500, HW36501, HW36502, HW36503, HW36504, HW36505, HW36506, HW36507, HW36508, HW36509, HW36510, HW36511, HW36513, HW36514, HW36515, HW36530, HW36553, HW36554, HW36555, HW36556, HW36557, HW36558, HW36559, HW36560, HW36561, HW36562, HW36563, HW36564, HW36595, HW36596, HW36597, HW36598, HW36599, HW36600, HW36601, HW36602, HW36603, HW36624, HW36625, HW36626, HW36628, HW36630, HW36631, HW36632, HW36633, HW36636, HW36637, HW36655, HW36659, HW36660, HW36662, HW36663, HW36664, HW36669, HW36670, HW36671, HW36672, HW36703, HW36704, HW36705, HW36708, HW36709, HW36710, HW36711, HW36712, HW36713, HW36853, HW36854, HW36855, HW36898, HW36899, HW36900, HW36903, HW36919, HW36921 GTIN 00888707002486, Serial Numbers: HW31444, HW31569, HW31673, HW31814, HW31817, HW31818, HW31820, HW31824, HW31825, HW31826, HW31872, HW31873, HW31875, HW31877, HW31927, HW31932, HW31934, HW31939, HW31940, HW31941, HW31995, HW31996, HW31997, HW31999, HW32002, HW32008, HW32009, HW32010, HW32011, HW32013, HW32032, HW32034, HW32038, HW32046, HW32053, HW32057, HW32062, HW32065, HW32071, HW32085, HW32109, HW32165, HW32166, HW32195, HW32205, HW32211, HW32221, HW32236, HW32243, HW32250, HW32506, HW34015, HW34122, HW34123, HW34124, HW34251, HW34252, HW34275, HW34277, HW34280, HW34354, HW34355, HW34356, HW34361, HW34364, HW34433, HW34434, HW34437, HW34439, HW34440, HW34442, HW34443, HW34444, HW34452, HW34454, HW34619, HW34620, HW34621, HW34622, HW34623, HW34624, HW34629, HW34630, HW34631, HW34636, HW34656, HW34719, HW34738, HW34739, HW34742, HW34748, HW34749, HW34750, HW34753, HW34757, HW34758, HW34761, HW34762, HW34767, HW34769, HW34779, HW34818, HW34853, HW34867, HW34873, HW34879, HW34880, HW34882, HW34885, HW34888, HW34890, HW34897, HW34898, HW34900, HW34905, HW34909, HW34911, HW34912, HW34945, HW34954, HW34960, HW35171, HW35228, HW35230, HW35278, HW35282, HW35283, HW35297, HW35298, HW35300, HW35303, HW35304, HW35306, HW35307, HW35512, HW35513, HW35514, HW35516, HW35517, HW35518, HW35519, HW35520, HW35521, HW35522, HW35523, HW35525, HW35526, HW35527, HW35528, HW35565, HW35567, HW35568, HW35569, HW35570, HW35593, HW35600, HW35612, HW35614, HW35615, HW35616, HW35617, HW35618, HW35645, HW35650, HW35652, HW35685, HW35725, HW35734, HW35737, HW35738, HW35740, HW35742, HW35743, HW35744, HW35745, HW35746, HW35747, HW35748, HW35751, HW35752, HW35760, HW35762, HW35765 GTIN 00888707002462, Serial Numbers: HW31586, HW31700, HW32035 GTIN 00888707002424, Serial Numbers: HW31698, HW31851 GTIN 00888707002448, Serial Numbers: HW31779, HW31780, HW32546, HW34095, HW34617, HW35398, HW35511, HW35589, HW35597  GTIN 00888707002455, Serial Numbers: HW31852, HW31856, HW32025, HW32198, HW34026, HW34637, HW35544 GTIN 00888707006019, Serial Numbers: HW31983, HW34720, HW34974, HW35376, HW35377, HW35849, HW35866, HW35869, HW35871, HW35873, HW35877, HW35878, HW35879, HW35880, HW35998, HW36000, HW36056, HW36057, HW36058, HW36059, HW36060, HW36061, HW36062, HW36063, HW36113, HW36114, HW36115, HW36116, HW36117, HW36118, HW36119, HW36120, HW36145, HW36146, HW36155, HW36156, HW36157, HW36158, HW36159, HW36167, HW36221, HW36222, HW36223, HW36350, HW36351, HW36352 GTIN 00888707006408, Serial Numbers: HW34292, HW35932, HW36083, HW36084, HW36087, HW36129, HW36130, HW36171, HW36172, HW36173, HW36212, HW36247, HW36250, HW36261, HW36263, HW36264, HW36265, HW36266, HW36348, HW36349, HW36413, HW36414, HW36415, HW36416, HW36594, HW36638 GTIN 00888707002554, Serial Numbers: HW34337, HW34362, HW34484, HW34591, HW34594, HW34625, HW34682, HW34693, HW34732, HW34833, HW34838, HW34846, HW34876, HW34884, HW34889, HW35052, HW35057, HW35061, HW35067, HW35316, HW35323, HW35359, HW35362, HW35363, HW35364, HW35458, HW35536, HW35585, HW35620, HW35622, HW35623, HW35709, HW35710, HW35728, HW35732, HW35758, HW35759, HW35764, HW35767, HW35771, HW35772, HW35775, HW35777, HW35780, HW35782 GTIN 00888707004558, Serial Numbers: HW34759, HW34785, HW35655, HW35656 GTIN 00888707002141, Serial Numbers: HW34848, HW34849, HW35711 GTIN 00888707006323, Serial Numbers: HW34982, HW35031, HW35379, HW35380, HW35381, HW35382, HW35383, HW35384, HW35388, HW35389, HW35390, HW35391, HW35392, HW35621, HW35642, HW35654, HW35712, HW35722, HW35727, HW35729, HW35736, HW35755, HW35770, HW35781, HW35783, HW35977, HW36024, HW36025, HW36027, HW36028, HW36029, HW36030, HW36032, HW36033, HW36034, HW36042, HW36043, HW36044, HW36045, HW36046, HW36064, HW36065, HW36072, HW36073, HW36074, HW36075, HW36076, HW36077, HW36078, HW36079, HW36080, HW36081, HW36082, HW36123, HW36124, HW36125, HW36126, HW36127, HW36128, HW36133, HW36134, HW36135, HW36136, HW36137, HW36139, HW36140, HW36141, HW36142, HW36143, HW36144, HW36147, HW36148, HW36149, HW36150, HW36151, HW36152, HW36153, HW36187, HW36188, HW36189, HW36190, HW36191, HW36202, HW36203, HW36204, HW36206, HW36207, HW36208, HW36209, HW36210, HW36234, HW36235, HW36236, HW36237, HW36238, HW36239, HW36242, HW36244, HW36245, HW36267, HW36268, HW36271, HW36272, HW36274, HW36275, HW36284, HW36286, HW36290, HW36291, HW36292, HW36293, HW36295, HW36296, HW36297, HW36339, HW36340, HW36342, HW36343, HW36344, HW36346, HW36364, HW36366, HW36367, HW36375, HW36378, HW36379, HW36380, HW36439, HW36440, HW36441, HW36443, HW36444, HW36445, HW36446, HW36450, HW36451, HW36452, HW36453, HW36454, HW36455, HW36456, HW36520, HW36521, HW36522, HW36524, HW36528, HW36529, HW36532, HW36533, HW36534, HW36535, HW36537, HW36539, HW36548, HW36549, HW36550, HW36551, HW36552, HW36604, HW36605, HW36606, HW36607, HW36608, HW36639, HW36640, HW36641, HW36645, HW36649, HW36651, HW36661, HW36674, HW36675, HW36676, HW36687, HW36714, HW36729, HW36731, HW36732, HW36733, HW36734, HW36735, HW36737, HW36738, HW36739, HW36744, HW36908, HW36909, HW36922, HW36923, HW36925, HW36932 GTIN 00888707005951, Serial Numbers: HW35279, HW35331, HW35503, HW35524, HW35581, HW35675, HW35715, HW35720, HW35739, HW35768, HW35787, HW35788, HW35789, HW35790, HW35791, HW35792, HW35793, HW35794, HW35795, HW35796, HW35797, HW35798, HW35799, HW35821, HW35822, HW35823, HW35824, HW35825, HW35826, HW35827, HW35831, HW35833, HW35834, HW35835, HW35836, HW35837, HW35838, HW35839, HW35840, HW35841, HW35842, HW35843, HW35844, HW35845, HW35846, HW35883, HW35887, HW35888, HW35889, HW35890, HW35891, HW35892, HW35893, HW35894, HW35895, HW35896, HW35897, HW35898, HW35900, HW35905, HW35906, HW35907, HW35921, HW35925, HW35926, HW35928, HW35930, HW35933, HW35934, HW35945, HW35946, HW35947, HW35948, HW35949, HW35950, HW35951, HW35952, HW35953, HW35954, HW35955, HW35956, HW35957, HW35959, HW35960, HW35961 GTIN 00888707002264, Serial Numbers: HW35741, HW35773 GTIN 00888707006316, Serial Numbers: HW35754, HW35774, HW35865, HW35868, HW35874, HW35940, HW35958, HW35962, HW35963, HW35964, HW35965 GTIN 00888707005968, Serial Numbers: HW35801, HW35802, HW35803, HW35804, HW35805, HW35806, HW35807, HW35808, HW35809, HW35810, HW35811, HW35812, HW35813, HW35814, HW35815, HW35816, HW35817, HW35818, HW35819, HW35820, HW35847, HW35848, HW35850, HW35851, HW35852, HW35853, HW35854, HW35855, HW35856, HW35857, HW35858, HW35859, HW35860, HW35861, HW35862, HW35863, HW35864, HW35867, HW35870, HW35875, HW35923, HW35924, HW35927, HW35929, HW35931, HW35935, HW35936, HW35937, HW35938, HW35939, HW35966, HW35967, HW35968, HW35969, HW35970, HW35971, HW35972, HW35973, HW35975, HW35976, HW35978, HW35988, HW35989, HW35990, HW35991, HW35993, HW35994, HW35995, HW35996, HW35997 GTIN 00888707006309, Serial Numbers: HW35876, HW35882, HW35884, HW35885, HW35886, HW35941, HW35942, HW35999 GTIN 00888707006347, Serial Numbers: HW35902, HW35903, HW35908, HW35909, HW35910, HW35911, HW35912, HW35913, HW35914, HW35915, HW35918, HW35920, HW36001, HW36002, HW36003, HW36016, HW36035, HW36036, HW36037, HW36038, HW36039, HW36040, HW36048, HW36049, HW36050, HW36051, HW36052, HW36053, HW36054, HW36055, HW36088, HW36089, HW36092, HW36093, HW36094, HW36095, HW36096, HW36097, HW36100, HW36101, HW36102, HW36103, HW36105, HW36106, HW36107, HW36108, HW36109, HW36110, HW36111, HW36112, HW36170, HW36540, HW36541, HW36542, HW36543, HW36544, HW36565, HW36566, HW36568, HW36569, HW36570, HW36571, HW36572, HW36573, HW36574, HW36575, HW36576, HW36577, HW36578, HW36579, HW36581, HW36582, HW36583, HW36584, HW36585, HW36586, HW36611, HW36612, HW36615, HW36616, HW36618, HW36619, HW36620, HW36621, HW36622, HW36623 GTIN 00888707006446, Serial Numbers: HW35979, HW35980, HW35982, HW35984, HW36160, HW36161, HW36162, HW36163, HW36164, HW36278, HW36287, HW36381, HW36382, HW36383, HW36384, HW36385, HW36386, HW36387, HW36388, HW36460, HW36462, HW36464, HW36465, HW36469, HW36470, HW36471, HW36472, HW36480, HW36481, HW36482, HW36483, HW36484, HW36486, HW36487, HW36489, HW36491, HW36492, HW36494, HW36495 GTIN 00888707006392, Serial Numbers: HW35986, HW35987, HW36066, HW36085, HW36086, HW36213, HW36214, HW36215, HW36216, HW36217, HW36218, HW36219, HW36220, HW36289, HW36311, HW36417, HW36418, HW36517, HW36587, HW36588, HW36589, HW36590, HW36652, HW36656, HW36860 GTIN 00888707007290, Serial Numbers: HW36421, HW36422 GTIN 00888707006354, Serial Numbers: HW36838, HW36880 No GTIN, Serial Numbers: HW26099, HW26126, HW26330, HW26660, HW26939, HW26940, HW27099, HW27452, HW27678, HW28063, HW28199, HW28373, HW28418, HW28895, HW28973, HW29073, HW29214, HW29298, HW29318, HW29351, HW29353, HW29354, HW29359

510(k) numbers

not on file

PMA numbers

["P100047"]

Product code

DSQ

Firm FEI

3007042319

Firm city

Miami Lakes

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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