Getinge faces Class I recall of potentially impaired emergency hand cranks on life support systems

Earlier this year, Getinge’s heart-lung support and permanent life support systems saw their CE marks be suspended over issues with their sterile packaging, and now, yet another of the Swedish devicemaker’s life support systems has hit a regulatory snag of its own.

Getinge began a recall of one component of its Cardiohelp extracorporeal life support systems in October, according to a notice from the FDA on Friday that gave the recall a Class I rating—the agency’s most serious, denoting a risk of serious injury or death associated with a recalled product.

The portable Cardiohelp system provides respiratory and circulatory support not only in the emergency room, but also for patients who are undergoing certain heart and lung procedures and those being transferred within or between hospitals. It works by moving a patient’s blood through a circuit outside the body to remove carbon dioxide and add needed oxygen to the blood.

Though the system can connect to an external power supply and also contains batteries, if either power source fails, it can continue to be used with the emergency drive, a detachable hand crank that’s turned to power the system—and it’s the emergency drive, in particular, that’s behind this fall’s recall.

The drives have been found to be at risk of blockages or other impairments that could keep them from being properly turned. According to the FDA’s notice, the issue stems from a “scrounger disc that interferes with the turning of the crank” and creates friction in the handle attachment, therefore making the emergency drive difficult to crank or completely stuck.

Getinge Cardiohelp life support system emergency drive

If that happens and a clinician isn’t able to operate the emergency drive as needed, preventing the delivery of necessary support to the heart and lungs, it could lead to ischemia, hypoxia, stroke or death, per the FDA—but so far, there haven’t been any such reports of injuries or deaths associated with the hand cranks.

The recall affects only two model numbers of the Cardiohelp emergency drives that were distributed between September 2022 through July of this year, encompassing 41 devices in the U.S.

In an October letter sent to Cardiohelp customers, Getinge asked that they immediately contact the devicemaker if they have any of the recalled drives and arrange to send them in for repairs; in the meantime, Getinge will send affected customers loaner devices.

This is the latest in a slew of Class I recalls for Getinge this year. Between January and August, the company racked up eight separate notices from the FDA regarding its Cardiosave intra-aortic balloon pumps.

The entire octet of recalls concern both the Hybrid and Rescue models of the pumps, which are designed to help keep the left ventricle pumping at a normal rhythm in patients experiencing cardiogenic shock.

The last four of the Class I tags arrived in a late August flurry and detailed instances in which the pumps were found to overheat, fail to properly fill, lose the regular flow of helium or unexpectedly shut down. At the time of the FDA’s notices, each of those issues had sparked complaints numbering in the hundreds, including reports of six total patient deaths.