Cardiosave Hybrid Intra-Aortic Balloon Pump. Model Numbers: D998-00-0800-31, D998-00-0800-32, D998-00-0800-33, D998-00-0
FDA device recall Z-1231-2023 · posted 2023-03-06 · Open, Classified
Recall details
- Recalling firm
- Datascope Corp.
- Reason for recall
- 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.
- Action taken
- 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/Getinge Technical Support at 1-888-943-8872, options 4, 2, 1, Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone). On 11/04/2025 the recall was expanded, and consignees were notified via letter. The notification was for awareness to the update of Datascope s preventative maintenance in the IFU addendum, which was provided to consignees. The IFU Addendum contains an updated Schedule B Preventive Maintenance Schedule which calls for the Quick Disconnect Fitting O-Ring to be replaced and to lubricate the console release latch every 12 months or 2500 hours. The Service Manual has contained this update to Preventive Maintenance for the Helium O-Ring since June 2023. Consignees were instructed to review the IFU Addendum and local Preventive Maintenance Schedule and update their Preventive Maintenance schedule accordingly.
- Root cause
- Equipment maintenance
- Status
- Open, Classified
- Product code
- DSP
- Quantity affected
- 11,792 units (5.408 US, 6,384 OUS)
- Distribution
- Nationwide US distribution. Worldwide international distribution.
- Date initiated
- 2023-02-07
- Date posted
- 2023-03-06
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CARDIOSAVE Intra-Aortic Balloon Pump (K181122) | Datascope Corp. | 2018-05-31 |