Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85

FDA device recall Z-2152-2023 · posted 2023-07-20 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

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.

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

Root cause

Component design/selection

Status

Open, Classified

Product code

DSP

Quantity affected

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, BELGIU

Date initiated

2023-06-05

Date posted

2023-07-20

Location

Mahwah, NJ

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