FDA Device recall Z-1230-2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85 by Datascope, citing there have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1230-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-07 |
| Published | 2023-03-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Datascope |
| Distribution | US |
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
Reason
There have been reported failures of the high pressure helium regulator, which may cause a helium leak in the Cardiosave Hospital Cart. In instance of helium regulator failure, a Pump Console s internal reservoir of helium will not be replenished when docked into an impacted Hospital Cart. This may result in an insufficient amount of helium within the internal reservoir.
Identifiers
| code_info | All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10…All Serial Numbers. Model Number: 0998-00-0800-75, UDI-DI: 10607567112312; Model Number: 0998-00-0800-83, UDI-DI: 10607567108407; Model Number: 0998-00-0800-85, UDI-DI: 10607567113449 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Datascope
- Battery Charging Station
FDA Device · Class III · 2026-03-25 · Datascope - CS300 IABP. Software Version CS300 IABP C.01
FDA Device · Class II · 2026-03-11 · Datascope - CS100 IABP. Software Version CS100 IABP Q.01
FDA Device · Class II · 2026-03-11 · Datascope - Cardiosave Rescue
FDA Device · Class III · 2025-12-24 · Datascope - Cardiosave Hybrid
FDA Device · Class III · 2025-12-24 · Datascope
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1230-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.