Recall Z-2152-2023
Datascope Corp. · initiated June 5, 2023
Class I – dangerous or defective products that could cause serious health problems or death
Product
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
Codes / lots: All Unit Serial Numbers Model UDI 0998-00-0800-75 10607567112312 0998-00-0800-83 10607567108407 0998-00-0800-85 10607567113449
Reason for recall
An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management Board and/or Solenoid Board. This issue may lead to an unexpected interruption of therapy.
FDA-determined cause: Component design/selection
Action taken
On June 5, 2023, the firm notified customers of the recall via "URGENT MEDICAL DEVICE CORRECTION" letters. Letters covered two issues: Issue 1 - Failure to charge battery (Covered by RES 92287) Issue 2 - Unexpected shutdown (Covered by this RES event) User Actions: Issue 2: Unexpected Shutdown due to failure of Tantalum Capacitors. Should loss of power occur, therapy will be interrupted and the console will need to be exchanged with another (if available) to resume therapy. If your device remains inoperable, please contact your service representative. It is recommended for users to have an alternate IABP on hand in the event that this issue may occur. The firm is developing a hardware correction to address this issue. If you have any questions, please contact your Datascope/Getinge representative or call 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. ET
Details
- Recall number
- Z-2152-2023
- Initiated
- June 5, 2023
- Posted by FDA
- July 20, 2023
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 9174 (4586 US; 4588 OUS) in total
- Distribution
- Worldwide Distribution- US (Nationwide) and OUS (foreign) countries of: ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, AZERBAIJAN , BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA and HERZEGOVINA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, C¿te d'Ivoire, CROATIA, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE…
- Recalling firm
- Datascope Corp., Mahwah, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2151-2023 Class I | Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31…An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power Management… | 06/05/2023Open, Classified |