FDA Device recall Z-1232-2023
Cardiosave Rescue
- FDA Device
- Class II
- ongoing
- Published 2023-03-15
On 2023-03-15 the FDA classified a Class II recall of Cardiosave Rescue by Datascope, citing firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is de….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1232-2023 |
| 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. Model Number: 0998-00-0800-83.
Reason
Firm has received reports of damaged, worn, or torn O-rings on the Cardiosave Pump Console quick disconnect fitting, which results in helium tank leaks. If the helium supply is depleted, therapy will be interrupted.
Identifiers
| code_info | Model Number: 0998-00-0800-83. UDI-DI: 10607567108407. All serial numbers. |
|---|
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-1232-2023%22
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