Recall Z-1232-2023 ยท DSP System, Balloon, Intra-Aortic And Control
Datascope Corp.
Cardiosave Rescue. Model Number: 0998-00-0800-83.
| Date | Mar 6, 2023 (initiated Feb 7, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Equipment maintenance |
| Action | Firm notified customers on February 7, 2023, in an Urgent Medical Device Correction letter which discussed four issues in total - this issue was Issue #4. Customers were instructed to contact their Datascope/Getinge service representative if they observe any visual damage to the O-ring installed as part of the quick disconnect fitting. Datascope/Getinge is currently updating the annual Preventive Maintenance instruction to include replacement of the quick disconnect fitting O-ring. If you have any questions, please contact your Datascope/Getinge representative or call the Datascope/Geting |
| Quantity | 47 units (44 US, 3 OUS) |
| Distribution | Nationwide US distribution. Worldwide international distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181122 | CARDIOSAVE Intra-Aortic Balloon Pump Datascope Corp., May 31, 2018 |