Datascope Corp. Recall 87482
Description: Cardiosave Rescue 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 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Datascope Corp. Recall 87482 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1507-2021 |
| Event ID | 87482 |
| Event Description | Cardiosave Rescue 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 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution. |
| Quantity | 7192 total |
| Recall 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). |
| Device Classification | 20210505 |
| Device Code Info | All Systems. UDI: 10607567112312 10607567108407 10607567113449 |
| Center Classification Date | 20210428 |
| Recall Initiation Date | 20210322 |
| Recalling Firm | Datascope Corp. |
| Initial Notification | Letter |
| Similar To |