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-2150-2023 · posted 2023-07-19 · Open, Classified

Recall details

Recalling firm

Datascope Corp.

Reason for recall

IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interrupted if batteries fail to charge and the device is disconnected from AC power. Low battery alarms may alert the User to the issue prior to 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 this RES event) Issue 2 - Unexpected shutdown (Covered by RES 92335) User Actions: Issue 1: IABP will not charge battery due to failure of the Power Management Board Charge Path Circuitry To prevent electrical surges that may impair the Cardiosave s ability to charge batteries, do not remove the battery from a Cardiosave when the battery level is at 80% or higher and actively charging (i.e successfully connected to AC power). Keep the battery in the charging bay until fully charged. 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

Device Design

Status

Open, Classified

Product code

DSP

Quantity affected

9174 (4586 US; 4588 OUS)

Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) to countries of: ALBANIA ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELARUS, BELGIUM, BOSNIA a

Date initiated

2023-06-05

Date posted

2023-07-19

Location

Mahwah, NJ

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