Cardiosave Hybrid Intra-Aortic Balloon Pump — Class II medical device recall Z-1276-2023
Ongoing recall by Datascope Corp., reported 2023-03-29. There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aorti
| Recall number | Z-1276-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2023-02-28 |
| Classified | 2023-03-22 |
| Reported by FDA | 2023-03-29 |
| Quantity | 391 iabps |
| UPC / GTIN / UDI-DI | 10607567108391, 10607567108414, 10607567108421, 10607567108438, 10607567109008, 10607567109053, 10607567109107, 10607567111117, 10607567113432 |
| Serial numbers | CA209023D2, CA211084E2, CA212105F2, CA212724F2, CA213851G2, CA214935H2, CA216307I2, CA217776J2, CA217786J2, CA222643A3, CA226551D3, CA226957D3, CA227974E3, CA227979E3, CA229121E3, CA237955K3, CA245024D4, CA246297E4, CA247925F4, CA249755G4, CA251232H4, CA251252H4, CA251720I4, CB293277L8, CB351043D2 and 355 more |
| Model numbers | 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 |
Product
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, and 0998-00-0800-65
Reason for recall
There is an issue related to the Safety Disk not meeting a performance requirement that may impact Intra-Aortic Balloon catheter (IAB) displacement volume. This potential failure of an impacted Safety Disk may lead to slightly reduced IAB inflation during therapy or a reduction in the degree of augmentation provided to the patient during therapy.
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-1276-2023. 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.