Cardiosave Hybrid and rescue IABP — Class II medical device recall Z-1248-2016
Terminated recall by Maquet Datascope Corp - Cardiac Assist Division, reported 2016-04-06, distributed nationwide. Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specific
| Recall number | Z-1248-2016 |
|---|---|
| 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 | 2015-12-16 |
| Classified | 2016-03-25 |
| Reported by FDA | 2016-04-06 |
| Terminated | 2018-06-01 |
| Distributed | Nationwide (US) |
Product
Cardiosave Hybrid and rescue IABP
Reason for recall
Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet the specifications for output pressure or vacuum at specific flow rates.
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-1248-2016. 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.