FDA MedWatch - Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) by Getinge/Datascope/Maquet:

U.S. Food and Drug Administration sent this bulletin at 12/29/2021 09:05 PM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) by Getinge/Datascope/Maquet: Class I Recall - Due to Reports of Fluid Leaks

AUDIENCE: Patient, Health Professional, Risk Manager, Cardiology

ISSUE: Getinge/Datascope/Maquet is recalling these products due to complaints of fluid leaks. Fluid entering the Cardiosave IABP may cause unexpected pump shutdown or the inability to initiate therapy.

There has been one death and 71 complaints reported about this device issue.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The CardioSave Hybrid/Rescue Intra-Aortic Balloon Pumps (IABP) are cardiac (heart) assist devices used with patients undergoing cardiac and non-cardiac surgery, and to treat adult patients who have acute coronary syndrome or complications of heart failure.

RECOMMENDATIONS: On November 15, 2021, Getinge/Datascope/Maquet sent an Urgent Medical Device Correction Letter to customers instructing them to:

Immediately examine inventory to determine if they have any Cardiosave Hybrid or Rescue IABPs.
Follow the Instructions For Use.
Never place fluids on top of the unit.
- In case of accidental spillage, wipe clean immediately and have the unit serviced to ensure no hazard exists.
Use the Plastic Weather Display and Rescue Cover any time the Cardiosave Rescue IABP is used outdoors, especially when there is the possibility of wet weather.

Getinge/Datascope/Maquet plans to correct all IABP devices in the field to include various internal and external component upgrades that will be made available in an Ingress Prevention Upgrade Kit and will be installed by a Getinge/Datascope service representative.

Customers will also receive redesigned Display and Rescue Covers for the Cardiosave transport console.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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