The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product

• Product Names: Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
• Manufacturing Dates: December 2011 to Present
• Model Numbers: See Links to Recall Database Below
• Distribution Dates: March 6, 2012 to October 21, 2021
• Devices Recalled in the U.S.: 4,338
• Date Initiated by Firm: October 27, 2021

Device Use

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.

 

Figure 1: Cardiosave HYBRID Intra-Aortic Balloon Pump

 

Figure 2: Cardiosave RESCUE Intra-Aortic Balloon Pump

Reason for Recall

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.

Who May be Affected

• Health care providers using the affected Cardiosave Hybrid/Rescue IABP
• Patients receiving circulatory support with affected Cardiosave Hybrid/Rescue IABP

What to Do

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.

Contact Information

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 a.m. and 6:00 p.m. EST.

Additional Resources:

• Medical Device Recall Database (Cardiosave Hybrid)
• Medical Device Recall Database (Cardiosave Rescue)
• Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure

How do I report a problem?

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, regular mail, or FAX.