Battery — Class II medical device recall Z-0050-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-17, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of
| Recall number | Z-0050-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Ann Arbor, MI, United States |
| Recall initiated | 2012-09-25 |
| Classified | 2012-10-11 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2014-01-15 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, DE, DO, EC, ES, FR, GR, HK, IN, IT, JP, KR, MX, MY, NL, PA, PE, PH, SA, SG, TH, TW, UY, VE, ZA |
| Quantity | 289 units |
| Reason classes | device malfunction |
| Lot numbers | 1001-1187, 1101, 1193-1286, 2018, 2083-2085, 2288, 2289, 2447-2451, 2634, 2635, 2884 |
| Model numbers | 9491 |
Product
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2004 of various malfunctions of the battery backup system for the Sarns" Centrifugal System. The reports can be broadly categorized as follows: " Failure to charge " Failure to hold charge " Failure to operate In the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. In
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0050-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.