Getinge is recalling the Cardiohelp System emergency drive over concern that it can become stuck or hard to turn due to friction being generated in the handle attachment, according to a medical device recall notice posted on the US Food and Drug Administration (FDA) website.
The FDA has identified this as a Class I recall, the most serious type due to the risk for serious injury or death. To date, there have been no reports of death or injuries associated with this recall.
The Cardiohelp System is a compact cardiopulmonary support system used for a range of indications in intensive care, emergency medicine, cardiology, and cardiac surgery.
Getinge is recalling the system's emergency drive "due to a possible blocking or impairment of the ability of the emergency drive to be cranked," the recall notice explains.
"If the emergency drive is needed, a clinician may not be able to turn the handle to drive the pump or may not be able to turn the handle as fast as is needed to adequately support the patient," the notice warns. "If this occurs, the patient will lose adequate hemodynamic support or gas exchange; the results of which could include ischemia, hypoxia, stroke, or death."
The recall includes 41 units distributed between September 14, 2022 and July 27, 2023, with model numbers 701048002 or 701076205.
The recalled emergency drives should be returned to Getinge for repair. The company will supply loaner replacements where needed. Getinge has sent an urgent medical device removal notice to all affected customers.
For questions about this recall, contact Getinge Technical Support at (888) 943-8872 (select option 4, 2, 1), Monday through Friday, between the hours of 8:00 AM and 6:00 PM Eastern Standard Time.
Adverse events with these or other devices should be reported to the FDA through MedWatch, its adverse event reporting program.
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