Cardiosave Rescue — Class II medical device recall Z-1232-2023
Ongoing recall by Datascope Corp., reported 2023-03-15, distributed nationwide. Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fi
| Recall number | Z-1232-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-02-07 |
| Classified | 2023-03-06 |
| Reported by FDA | 2023-03-15 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10607567108407 |
| Model numbers | 0998-00-0800-83 |
Product
Cardiosave Rescue. Model Number: 0998-00-0800-83.
Reason for recall
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
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-1232-2023. 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.