Class III — Datascope Corp.
| Recalling firm | Datascope Corp. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | 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). |
| 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 |
| Quantity | 10087 total |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Initiated | 2021-03-22 |
| Classified | 2021-04-28 |
| Recall number | Z-1506-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Datascope Corp. (Z-1506-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87482/
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