FDA designates recall of heart-lung machine emergency drive as class I
Click Here to Manage Email Alerts
Key takeaways:
- The FDA designated the recall of Getinge’s heart-lung machine emergency drive as class I, the most serious type.
- The drive’s crank can become stuck, leading to a lapse in hemodynamic support and gas exchange.
Getinge announced it is recalling its heart-lung machine emergency drive due to an issue that could prevent the ability of the emergency drive to be cranked.
The FDA has identified the recall of this device (Cardiohelp Emergency Drive) as a class I recall, the most serious type of recall as use of the device may cause injury or death.
Image: Adobe Stock
The device is designed to oxygenate and remove carbon dioxide from blood for to up 6 hours and to provide hemodynamic support or gas exchange for up to 6 hours during procedures not requiring cardiopulmonary bypass.
The emergency drive can become stuck or difficult to turn due to friction caused by a scrounger disc that interferes with its movement, according to an FDA alert.
If the emergency drive cannot be cranked when needed, the patient will lose adequate hemodynamic support or gas exchange which could result in ischemia, hypoxia, stroke or death, according to the alert.
The company previously sent an urgent medical device removal notice to all affected customers on Oct. 5, 2023.
The recall includes 41 devices distributed between Sep. 14, 2022, and July 27, 2023.
There have been no reported injuries or deaths related to this issue.
Click Here to Manage Email Alerts