CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used… — Class II medical device recall Z-0662-2013
Terminated recall by Maquet Cardiovascular, LLC, reported 2013-01-16. In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent
| Recall number | Z-0662-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular, LLC, Wayne, NJ, United States |
| Recall initiated | 2012-03-27 |
| Classified | 2013-01-09 |
| Reported by FDA | 2013-01-16 |
| Terminated | 2015-09-30 |
| Countries outside the US | AE, CN, DE, ES, FR, IT, LU, NL, PL, SE, TH |
| Quantity | 29 units |
| Reason classes | device malfunction |
Product
CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
Reason for recall
In the Cardiosave Intra-aortic Balloon Pump, there is a possibility that the coiled cord assembly, a prominent connector cord between the Cardiosave IABP housing and the dual display head which secured atop the IABP may fail as a result of mishandling.
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-0662-2013. 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.