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: CARDIOHELP Emergency Drive
- Product Codes: See Recall Database Entry
- Model Numbers: 701048002, 701076205
- Manufacturing Dates: August 11, 2022 through June 20, 2023
- Distribution Dates: September 14, 2022 to July 27, 2023
- Devices Recalled in the U.S.: 41
- Date Initiated by Firm: October 5, 2023
Device Use
The CARDIOHELP System helps oxygenate blood and remove carbon dioxide from it. It moves blood through a circuit outside the body to support the heart and lungs for up to six hours. It is also intended to support the heart and lungs during procedures not requiring cardiopulmonary bypass, again for up to six hours.
Reason for Recall
Getinge is recalling the CARDIOHELP Emergency Drive due to a possible blocking or impairment of the ability of the emergency drive to be cranked. The emergency drive can become stuck or difficult to turn due to friction being generated in the handle attachment. The stiff hand crank is caused by a scrounger disc that interferes with the turning of the crank.
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. If this occurs, the patient will lose adequate hemodynamic support or gas exchange; the results of which could include ischemia, hypoxia, stroke, or death.
There have been no reports of death or injuries associated with this issue.
Who May be Affected
- Healthcare providers who use the CARDIOHELP System to treat patients
- People undergoing treatment where the CARDIOHELP System is used to support blood flow or oxygen supply
