Dive Brief: 

• FDA on Thursday classified Getinge's heart assist pump recall as a Class I event after the device was linked to one patient's death, and problems with the pump shutting down or failing to initiate therapy were reported in 71 complaints.
• The Sweden-based company initiated the recall on Oct. 27 for devices carrying the product names Datascope/Getinge/Maquet Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps. It is the second Class I recall for the heart pump in late 2021, after the company warned customers in September of a potential battery failure issue in a small number of the devices.
• In a statement on its website, Getinge said it plans to correct all of its intra-aortic balloon pumps in the field with internal and external component upgrades starting in the first half of 2022.

Dive Insight:

The Getinge system provides circulatory support for patients undergoing cardiac as well as non-cardiac surgery and to treat those with acute coronary syndrome or heart failure complications. The recall was prompted by fluid leaking into the device that may cause the pump to shut down unexpectedly or prevent it from starting therapy.

Getinge, in its statement, said the fluid leaks may short-circuit electronic components in the device. The field correction planned for the first half of next year is intended to eliminate this fluid ingress, and is a further action after the company performed a correction to the devices in May 2018, Getinge said.

In all, the recall affects 4,338 devices in the U.S. that were manufactured from December 2011 to the present and distributed between March 6, 2012 and Oct. 21, 2021, the FDA said.

Getinge sent an urgent letter to customers on Nov. 15 directing them to follow the instructions for device use and to never place fluids on top of the unit. Any accidental spill should be wiped immediately and the device serviced to ensure that no hazards exist.

Customers are further advised to use the plastic weather display and rescue cover any time the Cardiosave Rescue device is used outdoors but especially if wet weather is possible. During the field correction, customers also will receive redesigned display and rescue covers for the Cardiosave transport console. Getinge said the Ingress Prevention Upgrade Kit will be installed by a company service representative.

Efforts to correct the fluid leak problem follow a Sept. 21 recall by Getinge that affected 137 battery packs for the heart assist devices, distributed between Sept. 23, 2017 and Aug. 17, 2021, the FDA said in a separate notice. The substandard battery packs could cause the device to stop working when operated by battery only.

The company received six reports related to shortened battery run-times, involving no injuries or deaths. However, patients are at risk of serious injury or death if battery failure were to cause the device to stop delivering therapy, the FDA said. The agency also cautioned of a potential for underreporting of the battery problem.

Getinge offered replacements of the defective batteries. The company said the cost for the field correction related to the fluid leak issue is not material, and it made a provision for it in previous quarters.