Sarns Disposable Centrifugal Pump with X-Coating — Class II medical device recall Z-2029-2014
Terminated recall by Terumo Cardiovascular Systems Corporation, reported 2014-07-23, distributed nationwide. During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
| Recall number | Z-2029-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Terumo Cardiovascular Systems Corporation, Elkton, MD, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-07-11 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2016-09-07 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| Lot numbers | QM03, QN07, RA09, RC07 |
Product
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Reason for recall
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
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-2029-2014. 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.