Sorin C5 Perfusion System — Class II medical device recall Z-0275-2013
Terminated recall by Sorin Group USA, Inc., reported 2012-11-14, distributed nationwide. Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin G
| Recall number | Z-0275-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sorin Group USA, Inc., Arvada, CO, United States |
| Recall initiated | 2012-09-19 |
| Classified | 2012-11-08 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-01-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, DE, DK, ES, FI, GB, IE, IN, IR, JP, LB, MA, PK, PL, TH, TR, ZA |
| Quantity | 2 units |
| Reason classes | specification failure |
| Serial numbers | 58E00135, 58E00136 |
| Model numbers | 58-00-00 |
Product
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Reason for recall
Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determin
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-0275-2013. 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.