Getinge Recalls CARDIOHELP Emergency Drive due to an Impaired or Inability to Turn the Drive
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.
Figure 1: CARDIOHELP with Emergency Drive on top
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
What to Do
On October 5, 2023, Getinge sent all affected customers an Urgent Medical Device Removal Notice.
The letter requested customers to:
- Immediately examine current inventory to determine if it includes any affected CARDIOHELP Emergency Drives.
- If affected product is currently being used in patient treatment, the customer should inform Getinge immediately at (888) 943-8872, option 1, option 1 and ensure that an alternate means of emergency support is available at all times, which may include a nonaffected Emergency Drive (if available) or a fully charged backup CARDIOHELP console.
- Ensure that they are contacted by Getinge to arrange for loaner replacement drives where needed and to arrange for the return of the affected Emergency Drives for repair.
- Alternatively, the customer can reach out to Getinge at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone) to arrange for the return of impacted devices and to receive loaner devices.
- Share this information to all current and potential CARDIOHELP users within the hospital/facility.
- Distributors who have shipped any affected products to customers, should forward this document to their attention for appropriate action.
- Complete and sign the attached response form to acknowledge receipt of this notification. Completed forms should be returned to Getinge by e-mailing a scanned copy to Cardiohelpedrive2023.qrc@getinge.com or by faxing the form to 1-866-351-3477.
Contact Information
Customers in the U.S. with questions about this recall should contact Getinge Technical Support at (888) 943-8872 (select option 4,2,1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time).
Additional Resources
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.