Urgent FDA Safety and Quality Concerns: Getinge Cardiosave Hybrid IABP devices

WHAT IS THIS?

An Urgent FDA Safety and Quality Concern Notice is communication sent by the FDA to health care providers and facilities about the FDAs’ continued safety and quality concerns with medical devices.

EVENT

Type of Event	Safety and Quality Concern Notice
Notice Qty	All Devices
Notice Date	May 2024
Notice Link	Link
Notes/Details	The FDA recommends that health care facilities transition away from use of these devices and seek alternatives, if possible. These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices.
Reason	The FDA continues to receive medical device reports (MDR) related to the problems even though Getinge/Maquet took corrective steps, including reinforcing information in the Instructions for Use as well as providing users with new actions they should take when using the IABP..

DEVICE

Manufacturer	Getinge/Maquet/Datascope
Model Names	Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices
Serial Number(s)	All

CUSTOMER/PATIENT ACTIONS

FDA Recommendations

Plan for alternative capital equipment to transition away from these Getinge cardiovascular devices:
- Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices.
- Getinge Cardiopulmonary bypass (CPB) devices including the Getinge/Maquet Cardiohelp system and HLS Sets.
Use alternative devices, if possible. If you don’t have alternatives and continue to use these devices:
- Review the FDA’s previous recommendations. Read any Urgent Medical Device Correction notices from Getinge and follow the recommendations.
- Be aware of the recalls related to these devices.
Report any issues or adverse events with Getinge devices to the FDA. For details on reporting, see Reporting Problems to the FDA.
Report any supply chain issues to the deviceshortages@fda.hhs.gov mailbox.

CONTACT INFORMATION

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

DISCLAIMER

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Recalls and Medical Equipment Maintenance Records for the Medical Equipment Industry including Consumers, Distributors and 3rd Party Resellers.

Equiptrack products and services are based only on information supplied to Equiptrack. Equiptrack does not have the complete history of every unique piece of equipment. Use the Equiptrack search as one important tool, along with an equipment inspection and functional check, to make a better decision about purchasing your next piece of used medical equipment.

My cart