CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP — Class I medical device recall Z-3134-2024
Ongoing recall by Datascope Corp., reported 2024-10-02. Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose
| Recall number | Z-3134-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2024-08-08 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, ID, IE, IN, IQ, IR, IT, JO, JP, KR, KW, LB, LT, MA, MX, MY, NL, NO, NZ, OM, PH, PL, PT, RS, SA, SE, SG, SK, TH, TR, TW, VN |
| Quantity | 5,475 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10607567108391, 10607567108414, 10607567108421, 10607567108438, 10607567109008, 10607567109053, 10607567109107, 10607567111117, 10607567111940, 10607567113432, 10607567114187 |
Product
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
Reason for recall
Firm has developed a software correction (Revision D.00) outside the US to mitigate product problems that pose a risk of hemodynamic instability and failure of transmission of clinical data in Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump devices.
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-3134-2024. 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.