Medtronic Emergency Response Systems, Inc.: LIFEPAK EXPRESS defibrillator

Recall number

Z-0837-2007

Recalling firm

Medtronic Emergency Response Systems, Inc.

Product

LIFEPAK EXPRESS defibrillator

Status

Terminated

Initiated

2006-10-05

Posted

2007-06-21

Terminated

2013-08-08

Reason

Premature battery depletion due to electrical component failure

Root cause

Nonconforming Material/Component

Action

Per request from Japan, the firm initiated action on 10/5/06 replacing the devices in Japan with new devices. On 3/2/07 the firm issued a Safety Alert letter dated February 2007 to consignees (with the exception of Japan), advising that the defibrillators have an identified, lead-free component that is susceptible to failure within the first 250 days after manufacture. Failure of this component might cause a short that will drain the battery and eventually render the device inoperative. The letter further states that the firm strongly recommends that the consignee immediately and on a regular basis, inspect their defibrillator(s) per the LIFEPAK CR Plus/EXPRESS Operating Instructions - Section 5 Caring for the Defibrillator. The letter also provides a website to allow consignees to enter their device serial number(s) to determine if their LIFEPAK CR Plus/LIFEPAK EXPRESS are included in the action. This recall strategy is subject to modification pending the performance of devices remaining on the market.

Quantity

Total of Express 1,006 units worldwide; amount does not include units distributed to Japan.

Distribution

Distribution is worldwide. The device is designed for non-professional users and are primarily used in public access defibrillator environments such as airports, schools, and public libraries.

Lot, serial or model codes

Serial Numbers are for units with lead free capacitor C177. The following list of Serial Numbers does not include units sent to Japan, as firm does not consider them to be part of its Safety Alert action.   Serial Numbers: 34344155, 34176900, 34176892, 34176894, 34176896, 34176899, 34335036, 34335035, 34352271, 34335029, 33954274, 33954276, 33954277, 33954279, 33954280, 33954282, 34303575, 34151174, 34285509, 34285510, 34285511, 34285512, 34285513, 34285514, 34285515, 34285516, 34046893, 34046894, 34046895, 34046896, 34250191, 34014954, 34018318, 34056524, 34104971, 34684122, 34046902, 34046903, 34298409, 34298410, 34298411, 34298412, 34298413, 34298414, 34298415, 34298416, 34298417, 34298418, 34298419, 34298420, 34298421, 34014928, 34014930, 34014931, 34046905, 34014963, 34014964, 34014965, 34014966, 34014967, 34011973, 33954246, 34014933, 34014936, 34350472, 34285528, 34304529, 34229704, 34229705, 34229706, 34250885, 34250891, 34250893, 34018321, 34350460, 34018307, 34018301, 34303983, 34285547, 34018305, 34018303, 34303980, 34032552, 34303977, 34091673, 34049712, 34051058, 34051084, 34051085, 34252107, 34051091, 34252072, 34056817, 34251936, 34252111, 34022894, 34022895, 34022896, 34022897, 34022898, 34022899, 34022900, 34022901, 34022902, 34022903, 34022904, 34022905, 34022906, 34022907, 34022908, 34022909, 34022910, 34022911, 34022912, 34022913, 34022914, 34022915, 34022916, 34022917, 34022918, 34022919, 34022920, 34022921, 34022922, 34022923, 34022924, 34022925, 34022926, 34022927, 34022928, 34022929, 34022930, 34022931, 34022932, 34022933, 34022934, 34022935, 34022936, 34022937, 34022938, 34022939, 34022940, 34022941, 34022942, 34022943, 34022944, 34022945, 34022946, 34022947, 34022948, 34022949, 34022950, 34022951, 34022952, 34022953, 34022954, 34022955, 34022957, 34022958, 34022959, 34022960, 34022961, 34022962, 34022963, 34022964, 34022965, 34022966, 34022967, 34022968, 34022969, 34022970, 34022971, 34022972, 34051026, 34051027, 34051029, 34051030, 34051031, 34051032, 34051033, 34051034, 34051035, 34051036, 34051037, 34051038, 34051039, 34051040, 34051041, 34051042, 34051043, 34051044, 34051045, 34051046, 34051048, 34051049, 34051050, 34051051, 34051052, 34051053, 34051054, 34051055, 34051056, 34051057, 34051059, 34051060, 34051061, 34051062, 34051063, 34051064, 34051065, 34051066, 34051067, 34051068, 34051069, 34051070, 34051071, 34051072, 34051073, 34051074, 34051075, 34051076, 34051077, 34051078, 34051079, 34051080, 34051081, 34051083, 34051086, 34051087, 34051088, 34051089, 34051090, 34051092, 34051093, 34051094, 34051095, 34051096, 34051097, 34051098, 34051099, 34051100, 34051101, 34051102, 34051104, 34051105, 34053120, 34309063, 34309064, 34309065, 34309066, 34309067, 34309068, 34309069, 34309071, 34309072, 34309073, 34309074, 34309075, 34309076, 34309077, 34309093, 34309094, 34309097, 34309098, 34309099, 34309100, 34309101, 34309102, 34309103, 34309104, 34309105, 34309106, 34309107, 34309109, 34309110, 34309111, 34309112, 34309113, 34309114, 34309116, 34309117, 34309118, 34309120, 34309121, 34309122, 34309123, 34309124, 34309125, 34309126, 34309127, 34309128, 34309168, 34309172, 34309176, 34309178, 34309181, 34309187, 34309189, 34309193, 34309195, 34309197, 34309201, 34309202, 34309204, 34309206, 34309207, 34309209, 34309211, 34309212, 34309214, 34309216, 34309217, 34309219, 34309220, 34309222, 34309223, 34309225, 34309233, 34309235, 34309236, 34309238, 34309240, 34309190, 34252101, 34285554, 34285555, 34285556, 34285557, 34285558, 34285559, 34309192, 34252115, 34352277, 34352278, 34352279, 34051103, 34217097, 34467124, 34467125, 34467126, 34482065, 34067612, 34330527, 34330528, 34330531, 34330532, 34330533, 34330534, 34330535, 34330538, 34330539, 34330540, 34330542, 34330543, 34330544, 34330546, 34330568, 34330572, 34047159, 34047160, 34047161, 34047162, 34047163, 34047164, 34047165, 34047166, 34047167, 34047168, 34047169, 34047170, 34047171, 34047172, 34047173, 34047174, 34047175, 34047176, 34047177, 34047178, 34047179, 34047180, 34047181, 34047182, 34047183, 34047184, 34047185, 34047186, 34047187, 34047188, 34047189, 34047190, 34047191, 34047192, 34047193, 34047195, 34047196, 34047197, 34043693, 33923349, 33923350, 33923352, 33923353, 33923357, 34066260, 34234400, 34234401, 34234402, 34234403, 34234404, 33928259, 34476797, 34682138, 34352630, 34230262, 34230263, 34230264, 34230265, 34230266, 34230267, 34230268, 34230269, 34046385, 34056336, 34056762, 34085482, 34085483, 34300513, 34050928, 34050930, 34050932, 34056342, 34056343, 34069952, 34087890, 34352568, 34056360, 34056361, 34056771, 34300481, 34300482, 34051082, 34056339, 34144650, 34144651, 34034052, 34085487, 34235978, 34462172, 34104969, 34208309, 34208310, 34208313, 34309256, 34104970, 33928020, 34309247, 34250207, 34250197, 34250204, 34250208, 34250195, 34250205, 34037755, 34037756, 34352738, 34250206, 34250209, 34250196, 34018313, 34018315, 34350433, 34056526, 34056527, 34056529, 34056772, 34309242, 34309243, 34309246, 34309248, 34309260, 34309264, 34330600, 34328806, 34328807, 34303805, 34316106, 34316120, 34255361, 33924004, 34018329, 34059342, 34335256, 34335257, 34335260, 34335264, 34225876, 33934824, 33934835, 34285563, 34309244, 34476272, 33934833, 34330121, 34120198, 34120199, 34120200, 34120202, 34120203, 34120204, 34120205, 34120206, 34120207, 34120208, 34120209, 34120210, 34120211, 34120212, 34066777, 34250905, 34250906, 34250907, 34250908, 34250909, 34250910, 34250911, 34250912, 34250913, 34250914, 34250915, 34096281, 34032829, 34066778, 34066779, 34066780, 34482253, 34222370, 34309245, 33955700, 34309257, 34056528, 34056525, 34056522, 34018332, 34056521, 34087747, 34251926, 34018310, 34208330, 33974362, 33974357, 33974358, 33974359, 33974360, 33974361, 33974363, 34684113, 34069936, 34069937, 34056802, 34056803, 34085478, 34085479, 34086761, 34086762, 34086763, 34086764, 34086765, 34303967, 34309249, 34056705, 34056706, 34056707, 34056708, 34056709, 34124843, 34217071, 34230247, 34037736, 34062533, 34249908, 34249909, 34285530, 34335281, 34335282, 34335283, 34335285, 34335286, 34335287, 34335291, 34335293, 34335294, 34335295, 34018335, 34014941, 34350499, 34209430, 34209433, 34039298, 34018323, 34267821, 34267823, 34267824, 34267825, 34267827, 34267829, 34267830, 34267831, 34267832, 34267833, 34267834, 34267835, 34267836, 34267837, 34267839, 34267840, 34267841, 34267842, 34267843, 34267828, 34229708, 34459857, 34176902, 34327649, 34309262, 34466935, 34327631, 34264717, 34264718, 34264719, 34264730, 34264731, 34264724, 34264725, 34264726, 34264727, 34018450, 34327645, 34330949, 34044786, 34044790, 34044792, 34264630, 34264631, 34264632, 34264633, 34314929, 34314930, 34039310, 34039311, 34039312, 34039313, 34039316, 34087355, 34087356, 34124846, 34264680, 34264682, 34264683, 34039314, 34039315, 34039318, 34039309, 34039317, 34018292, 34018296, 34018299, 34264664, 34264665, 34264666, 34264667, 34264668, 34264669, 34264670, 34264671, 34264672, 34264673, 34018448, 34004030, 34460685, 34481138, 34482528, 34094315, 34094316, 34094317, 34094318, 34094319, 34094320, 34094321, 34094322, 34094323, 34094324, 34094325, 34094326, 34345445, 34345440, 34478433, 34003998, 34003999, 34004000, 34004001, 34004002, 34046859, 34046860, 34046878, 34046874, 34047363, 34047364, 34047368, 34047375, 34047376, 34047377, 34285481, 34285482, 34285483, 34285506, 34003252, 34003253, 34003254, 34003255, 34003256, 34046876, 34002807, 34002808, 34002804, 34003052, 34003053, 34003054, 34003265, 34003266, 34003267, 34003268, 34003269, 34003270, 34003271, 34002956, 34285497, 34285499, 34285501, 34285503, 34285507, 34285508, 34285495, 34003981, 34003982, 34005490, 34285476, 34004344, 34047373, 34003277, 34003278, 34003279, 34014917, 34047365, 34047372, 34047342, 34047366, 34002806, 34285494, 34046885, 34046886, 34046887, 34004018, 34004019, 34004021, 34004022, 34004023, 34004024, 34004366, 34285500, 34004075, 34004337, 34004339, 34285505, 34046881, 34004120, 34047343, 34047369, 34285504, 34002789, 34002790, 34002792, 34002793, 34002794, 34002795, 34002796, 34002797, 34047339, 34047335, 34047374, 34004009, 34004010, 34002946, 34002947, 34002948, 34002949, 34002950, 34002951, 34002952, 34002953, 34046872, 34004364, 34047341, 34046864, 34047336, 34047338, 34047340, 34047344, 34002936, 34285496, 34004032, 34285502, 34047367, 34047371, 34047370, 34285484, 34285475, 34285493, 34285498, 34046870, 34285480, 34047337, 34046866, 34285478, 34285479, 34004192, 34004330, 34004331, 34004332, 34002805, 34264652, 34264653, 34264742, 34264743, 34264744, 34264745, 34264746, 34264747, 34281313, 34352070, 34018297, 34264734, 34264735, 34018294, 34044711, 34234275, 34009256, 34002662, 34044681, 34018290, 34018291, 34018293, 34018295, 34018298, 34343761, 34343772, 34343774, 34343775, 34343777, 34343790, 34343799, 34682300, 34264689, 34264690, 34264691, 34264692, 34264693, 34264699, 34264701, 34264702, 34264703, 34264707, 34264708, 34264709, 34333589, 34327647, 34144829, 34351843, 34351827, 34104972, 34069584, 34069585, 34069586, 34069587, 34069588, 34069589, 34069590, 34144830, 34144831, 34351850, 34144827, 34456426, 34482256, 34264712, 34264713, 34327629, 34482259, 34014938, 34328878, 34062568, 34062569, 34062570, 34285526, 34058294, 34309250, 34309252, 34337442, 34289601, 34290045, 34290147, 34290148, 34290149, 34290150, 34290151, 34290152, 34290153, 34290154, 34290155, 34290156, 34290157, 34290158, 34290159, 34290160, 34290161, 34290162, 34290163, 34290164, 34290165, 34290166, 34290167, 34290168, 34290169, 34290170, 34290171, 34290172, 34290173, 34290176, 34290177, 34290178, 34290180, 34290181, 34290182, 34290183, 34290184, 34290186, 34290187, 34290188, 34290189, 34290190, 34290191, 34290192, 34290193, 34290194, 34290195, 34290196, 34290197, 34290198, 34290199, 34290200, 34290201, 34290202, 34290204, 34290205, 34290209, 34290212, 34290217, 34290219, 34290225, 34290226, 34290228, 34290229, 34290230, 34290231, 34290232, 34290233, 34290234, 34290235, 34290236, 34290237, 34290238, 34290239, 34290243, 34290245, 34290246, 34290247, 34290248, 34290249, 34290251, 34290252, 34290253, 34290254, 34290255, 34290256, 34345858, 34345867, 34346123, 34318014, 34325153, 34325155, 34325156, 34325157, 34325158, 34325159, 34325296, 34325356, 34325357, 34325358, 34325359

510(k) numbers

["K011144"]

PMA numbers

not on file

Product code

MKJ

Firm FEI

3015876

Firm city

Redmond

Firm state

WA

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

Copy