Cardiosave Rescue Intra-Aortic Balloon Pump — Class II medical device recall Z-2616-2021
Ongoing recall by Datascope Corp., reported 2021-10-06, distributed nationwide. The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is ins
| Recall number | Z-2616-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-09-08 |
| Classified | 2021-09-30 |
| Reported by FDA | 2021-10-06 |
| Distributed | Nationwide (US) |
| Model numbers | 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 |
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason for recall
The Cardiosave IABP may unexpectedly shut down when the device is running on AC power, only one battery is installed in the IABP, and the battery is physically removed while the battery is being charged. This occurs during a very specific set of conditions.
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-2616-2021. 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.