August 31, 2023

The U.S. Food and Drug Administration (FDA) is providing an update about device failures for Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices. The FDA is issuing this letter to help ensure health care providers are aware of the latest recalls and recommendations to users.

Since June 2023, Getinge/Maquet/Datascope initiated additional voluntary recalls related to the potential for device failure with Cardiosave Hybrid and Rescue IABP devices and provided mitigation strategies.  Six of these recalls the FDA classified as Class I. Cardiosave IABP devices may unexpectedly shutdown or interrupt therapy (pump stops) due to:

• Electrical failures in the Power Management Board or Solenoid Board (Power Source Path),
• Failures in the printed circuit board assembly (PCBA) in the charging path,
• The device not being seated into the cart (which provides AC power) correctly, which means the device is unexpectedly running on battery power and unable to charge the batteries, 
• The device is unable to refill the helium (the gas used to inflate the balloon) to continue therapy (autofill failures), which means therapy will stop, 
• Sensitive high priority Gas Gain or Gas Loss alarms, which will stop therapy until corrected or the IABP device is replaced,
• Internal device temperature exceeds a threshold of 80° C (176°F), which stops therapy.  

The FDA continues to work with the manufacturer to evaluate these issues. 

While the FDA remains concerned about device shutdown and pump stop events, these devices may continue to be used to provide circulatory support when necessary. The FDA recognizes that alternative treatments are limited.

Recommendations

• Be aware that device failures continue to be observed with Cardiosave IABP devices. This is occurring while the device is running on battery power or AC power.
• Strongly consider having additional charged IABP devices available and ready in the event of device failure.
• Review the recent Urgent Medical Device Correction notices from Getinge/Maquet/Datascope, which provide additional information on issues related to the potential for device failure with Cardiosave Hybrid and Rescue IABP devices, recommendations to users, and Unique Device Identifier (UDI) information:
  • Urgent Medical Device Correction dated June 5, 2023, 
  • Urgent Medical Device Correction dated July 31, 2023,
  • Urgent Medical Device Correction dated July 31, 2023 
• Report any issues or adverse events with IABP devices, including therapy interruptions of any kind, to the FDA. For details on reporting, see Reporting Problems to the FDA.
• When possible, return devices associated with, or suspected to be associated with, any adverse events or device malfunction or failure to the manufacturer for evaluation to help them and the FDA better understand the issue.
• Contact Getinge if you have any questions about the recent Cardiosave recalls or did not receive the manufacturer’s customer letters, at 1-888-943-8872, Monday through Friday, between 8:00 a.m. and 6:00 p.m. EST. 

Background

The IABP is a cardiac assist device placed in the artery that is in the chest and abdomen (descending aorta). The device is an electromechanical system used to inflate and deflate intra-aortic balloons. These systems provide temporary support to the heart's left ventricle through counter pulsation.  An interruption in treatment using IABP can result in serious patient injury or death.

Getinge/Maquet/Datasope no longer manufactures the CS300 and CS100/CS100i IABP devices. While these devices may still be in use, they are not affected by the June 2023 and July 2023 recalls related to device failure. The currently available Getinge/Maquet/Datascope IABP devices are the Cardiosave Hybrid and Rescue.

Since 2017, the FDA has been evaluating and monitoring medical device reports of Getting/Maquet/Datascope Cardiosave IABP devices shutting down and therapy interruptions (pump stops). At this time, the extent of the root causes or incidence rate of device failure, shutdown and/or pump stop with Getinge/Maquet/Datascope Cardiosave IABP devices is not known. 

FDA Actions

The FDA has identified six of the latest Cardiosave Hybrid and Rescue IABP recalls as Class I, the most serious type of recall:

• Unexpected Shutdown-Electrical Failures in the Power Management Board or Solenoid Board (Power Source Path) 
• PCBA Failures Affecting the Ability to Charge the Batteries Leading to Unexpected Shutdowns 
• Power Failures When IABP is Unseated from the Cart
• Autofill Failure Alarms
• Gas Loss and Gas Gain Failures 
• System Over Temperature Alarms Causing Pump Stops 

Information on additional recalls can be found at Medical Device Recalls.

The FDA will continue to monitor issues with Cardiosave IABP devices, and the actions being taken by the manufacturer to address device failure.

The FDA continues to work with the manufacturer to understand the factors contributing to the device failures, as well as possible mitigation strategies. The mitigation strategies may include changes to the IABP device design and labeling.  

The FDA will keep the public informed if significant new information or recommendations become available.

Previous FDA Communications 

A timeline and summary of the FDA’s previous communications related to Getinge/Maquet/Datascope IABP devices is provided below.

Unique Device Identifier (UDI)

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. For more information on UDI, please visit Unique Device Identification System (UDI Systems). 

Reporting Problems to the FDA

If you are experiencing supply issues, contact the FDA about a medical device supply chain issue. Reporting supply issues informs the FDA of how it may be able to help address device supply availability. 
The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with Getinge Maquet/Datascope IABP devices.

• Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program.
• Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.
• Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.

Contact Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).