Terumo Cardiovascular Systems Corporation: CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.

Recall number

Z-1379-2012

Recalling firm

Terumo Cardiovascular Systems Corporation

Product

CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.

Status

Terminated

Initiated

2012-02-03

Posted

2012-04-06

Terminated

2013-08-29

Reason

Replacement of the SBC batteries (system batteries) should be managed as "routine maintenance" instead of as an in-house Service Procedure because some systems may be relying on batteries beyond their useful life.

Root cause

Labeling design

Action

On 2/3/12 all consignees received an URGENT MEDICAL DEVICE RECALL letter via Federal Express. The letter described the reason for the recall, identified the affected product population, what to do in the event of a failure, the potential hazard, and correction. Terumo CVS will update the Operator's Manual for the CDI 500 with instructions to replace the battery within its useful life. Users are to review the notice and ensure that all users are made aware of the issue. In addition, the Customer Response Form should be completed and returned. Users can contact their local Terumo Cardiovascular Systems representative or call 1-800-521-2818 with questions or concerns, to check the last time system batteries were replaced, or to schedule maintenance for systems approaching 10 years.

Quantity

3,829 units

Distribution

Worldwide Distribution -- USA, including the states of AK, AL, AR, AZ, CA, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, WV, WA, and WI and the countries of Japan, Germany, Barbados, Saudi Arabia, Columbia, Uruguay, Ecuador, Trinidad, Costa Rica, Paraguay, Panama, Belgium, Jordan, Libya, Mexico, Brazil, Honduras, Canada, Korea, Dominica Republic, El Salvador, Guatemala, Vietnam, Chile, Hong Kong, United Arab Emirates, Singapore, Australia, Malaysia, Taiwan, Philippines, Mexico, Thailand, Vietnam, and South Africa.

Lot, serial or model codes

500AHCT CDI Blood Parameter Monitoring TBD System 500 with Arterial blood parameter module and Hematocrit/ Saturation probe: 1023, 1025-1027, 1029-1031, 1034, 1035, 1037, 1040, 1045, 1048, 1054-1058, 1060-1062, 1064, 1065, 1072-1074, 1076-1095, 1098-1100, 1102, 1106-1110, 1114, 1116-1129, 1131, 1132, 1141-1145, 1153-1165, 1169-1180, 1186-1191, 1194-1210, 1212-1215, 1221-1230, 1236-1243, 1249-1253, 1256-1260, 1265-1269, 1275-1284, 1290-1294, 1300-1303, 1310, 1311, 1316-1320, 1322-1331, 1335-1339, 1345-1349, 1359-1378, 1384-1388, 1394-1398, 1409-1413, 1419, 1434-1438, 1444-1448, 1454-1458, 1469-1478, 1481, 1482, 1484-1493, 1495-1503, 1505-1520, 1528, 1531-1553, 1555-1558, 1567-1596, 1607-1616, 1632-1636, 1647-1656, 1667-1671, 1677-1681, 1687-1696, 1702-1711, 1717-1721, 1728-1732, 1738-1753, 1759-1775, 1777-1786, 1790-1794, 1796-1804,1810-1814, 1820-1829, 1831-1843, 1847-1850, 1856, 1861-1885, 1891-1900, 1906-1915, 1921-1925, 1931-1935, 1941-1950, 1975, 1986-2015, 2017-2022, 2024-2027, 2039, 2041-2044, 2046-2058, 2064, 2068, 2069, 2078-2085, 2087-2096, 2108, 2116, 2118-2122, 2132-2137, 2143- 2148, 2156-2176, 2183, 2184, 2188, 2191-2194, 2200-2213, 2215, 2220-2223, 2225-2227, 2232-2242, 2247, 2248, 2254, 2259, 2261, 2262, 2264, 2269-2272, 2278, 2280-2284, 2292-2294, 2299-2312, 2330-2337, 2353, 2359-2363, 2376, 2378-2388, 2398-2402, 2409-2416, 2427-2431, 2437, 2438, 2445-2452, 2459-2462, 2468, 2469, 2473-2475, 2484-2486, 2505-2513, 2518-2520, 2526-2540, 2557-2564, 2583-2586, 2604-2628, 2643-2645, 2648-2655, 2657-2660, 2663, 2681-2688, 2692-2694, 2697-2699, 2709, 2717-2721, 2728-2736, 2738-2741, 2748-2756, 2774-2782, 2785-2787, 2789-2792, 2796-2799, 2803, 2809-2814, 2821-2836, 2840-2845, 2850-2859, 2861-2864, 2871-2879, 2896-2900, 2903-2905, 2909-2912, 2916-2919, 2922, 2923, 2927-2936, 2941, 2948-2951, 2953-2957, 2976-2978, 2984-2989, 3000-3007, 3014-3021, 3028-3039, 3042-3051, 3056-3072, 3076-3082, 3088-3095, 3097-3114, 3117-3124, 3126-3130, 3136-3138, 3147-3151, 3154, 3163-3168, 3183-3189, 3197-3213, 3221-3224, 3229-3231, 3233-3237, 3246, 3247, 3250-3260, 3269-3286, 3290, 3307-3313, 3324-3328, 3335-3339, 3350-3353, 3358-3368, 3374-3382, 3392, 3393, 3398-3401, 3407-3409, 3411-3415, 3428-3433, 3438-3440, 3448, 3457, 3463-3468, 3473-3479, 3483-3488, 3491-3499, 3504-3508, 3511-3517, 3519-3533, 3536-3540, 3546-3570, 3574-3589, 3610, 3611, 3620-3623, 3632-3635, 3640-3642, 3649-3660, 3662-3668, 3682-3697, 3704-3714, 3717-3721, 3727-3737, 3745-3752, 3758-3768, 3781-3783, 3788-3798, 3805-3810, 3817-3826, 3831-3837, 3842-3851, 3882-3891, 3900, 3901, 3907-3911, 3922, 3923, 3932-3936, 3953-3961, 3966-3970, 3975-3985, 3990-3994, 3999-4005, 4030-4037, 4044-4049, 4056-4069, 4076-4081, 4090-4095, 4100-4104, 4109-4113, 4133-4142, 4149-4168, 4186-4202, 4213-4218, 4225-4229, 4242-4259, 4281-4289, 4300-4306, 4311-4317, 4324-4334, 4345-4350, 4353-4371, 5011-5035, 5040-5047, 5057-5064, 5078-5081, 5086-5093, 5102-5117, 5126-5141, 5150-5157, 5170-5177, 5180-5189, 5191-5196, 5199-5209, 5214-5221, 5226-5237, 5246-5249, 5254-5273, 5278-5281, 5286-5289, 5294-5297, 5306-5317, 5322-5329, 5345-5348, 5350-5353, 5358-5369, 5375-5382, 5387, 5388, 5500-5515, 5527-5531, 5542-5556, 5562-5564, 5566, 5569, 5571, 5572, 5574-5577, 5581-5583, and 5593-5600.

510(k) numbers

["K972962"]

PMA numbers

not on file

Product code

DRY

Firm FEI

1828100

Firm city

Ann Arbor

Firm state

MI

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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