Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump — Class II medical device recall Z-1140-2015
Terminated recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2015-03-04, distributed nationwide. Power supply malfunction complaints related to suboptimal thermal management.
| Recall number | Z-1140-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Datascope Corp - Cardiac Assist Division, Mahwah, NJ, United States |
| Recall initiated | 2015-01-30 |
| Classified | 2015-02-23 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2017-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 1,300 units |
| Reason classes | device malfunction |
Product
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Reason for recall
Power supply malfunction complaints related to suboptimal thermal management.
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-1140-2015. 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.