Cardiosave Hybrid IABP — Class III medical device recall Z-1506-2021
Ongoing recall by Datascope Corp., reported 2021-05-05, distributed nationwide. There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in
| Recall number | Z-1506-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Datascope Corp., Mahwah, NJ, United States |
| Recall initiated | 2021-03-22 |
| Classified | 2021-04-28 |
| Reported by FDA | 2021-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 10,087 total |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 10607567108391, 10607567108414, 10607567108421, 10607567108438, 10607567109008, 10607567109107, 10607567111117, 10607567111940, 10607567113432 |
| Model numbers | 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 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 IABP - Product Usage: used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation, Model Numbers 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65
Reason for recall
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
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-1506-2021. 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.