FDA Device recall Z-2487-2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 by Datascope, citing users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2487-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-31 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
Reason
Users were experiencing a failure in the IAB Fiber Optic Sensor input on the IABP when inserting the Intra-Aortic Balloon Fiber Optic connector.
Identifiers
| code_info | All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2487-2023%22
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