FDA Announces Recall of Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue IABPs

December 16, 2021—FDA advised that the Getinge Group has recalled the Cardiosave Hybrid and Cardiosave Rescue intra-aortic balloon pumps (IABPs; Getinge/Maquet/Datascope) because of reports 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, noted the advisory.

The CardioSave Hybrid/Rescue IABPs are cardiac assist devices used with patients undergoing cardiac and noncardiac surgery and to treat adult patients who have acute coronary syndrome or complications of heart failure.

In the advisory, the FDA has identified this as a Class I recall, indicating that use of these devices may cause serious injuries or death.

On November 15, 2021, Getinge/Datascope/Maquet sent an Urgent Medical Device Correction Letter to customers with these instructions:

• 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.

According to the FDA, the company 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.

The FDA noted that health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form or by regular mail or fax. Customers who have questions about this recall should contact their Getinge/Datascope/Maquet Sales Representative or call Customer Service at 1-888-943-8872 and press option 2, Monday through Friday between 8:00 am and 6:00 pm EST.

On September 21, the company initiated a Class I recall of the Cardiosave Hybrid/Rescue IABP battery packs because of the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting performance specifications being released to customers, which may cause the device to stop working when operated by battery only. The company reported receiving six complaints and no reports of injuries or deaths related to this issue as of the time of the notice.