Sarns Centrifugal System Control module — Class II medical device recall Z-0052-2013
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2012-10-17, distributed nationwide. Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subs
| Recall number | Z-0052-2013 |
|---|---|
| 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 | 2012-09-24 |
| Classified | 2012-10-11 |
| Reported by FDA | 2012-10-17 |
| Terminated | 2013-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BD, BE, BR, CA, CL, DE, DO, EC, GT, HK, IN, JP, KR, MX, SG, TH, TW, ZA |
| Quantity | 213 units |
| Serial numbers | 5007, 5028-5030, 5032, 5075, 5076, 5135, 6010, 6013, 6025, 6030, 6116, 7000-7197, 7372, 7373 |
| Model numbers | 6380 |
Product
Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Reason for recall
Terumo Cardiovascular Systems (Terumo CVS) received one report of loss of power to the control module and subsequently the drive motor for the Sarns centrifugal system during cardiopulmonary bypass.
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-0052-2013. 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.