MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump — Class II medical device recall Z-1462-2023
Ongoing recall by Datascope Corp., reported 2023-05-03. The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the
| Recall number | Z-1462-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-04-04 |
| Classified | 2023-04-26 |
| Reported by FDA | 2023-05-03 |
| Countries outside the US | BR |
| Quantity | 54 units |
| UPC / GTIN / UDI-DI | 10607567111117 |
| Serial numbers | CB307111G9, CB307112G9, CB307113G9, CB307114G9, CB307117G9, CB307119G9, CB311675I9, CB311676I9, CB311677I9, CB314092J9, CB314093J9, CB314094J9, CB319726D0, CB319727D0, CB320620E0, CB320621E0, CB320622E0, CB320623E0, CB320624E0, CB320625E0, CB322068F0, CB328500J0, CB329943K0, CB342652J1, CB342653J1 and 29 more |
| Model numbers | 0998-XX-0800-32 |
Product
MAQUET CARDIOSAVE hybrid Intra-Aortic Balloon Pump, Model Number 0998-XX-0800-32
Reason for recall
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
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-1462-2023. 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.