Devices

FDA on Ongoing Getinge Device Concerns

FDA is alerting healthcare providers and facilities about its ongoing safety and quality concerns with some Getinge/Maquet cardiovascular medical devices. The affected devices are the Getinge/Maquet/Datascope hybrid and rescue intra-aortic balloon pump (IABP) devices and the Getinge/Maquet Cardiohelp system and HLS sets.

A 5/8 letter to healthcare providers says the agency recommends that facilities transition away from using the devices and seek alternatives, if possible. “These recommendations are based on our continued concerns that Getinge/Maquet has not sufficiently addressed the problems and risks with these recalled devices,” the letter says.

The agency says it continues to receive medical device reports related to the problems, even though the company took corrective steps, including reinforcing information in the Instructions for Use and providing users with new actions they should take when using the IABP.

FDA says it recognizes that alternative treatment options are limited and provides recommendations for providers when the affected devices are used.

The letter says that from 1/1/2023 through 4/11 Getinge initiated 12 recalls in the U.S. for the Cardiosave IABP. FDA classified eight of them as Class 1. In the last 12 months, it says, it has received 2,964 medical device reports related to the pumps, with 15 reported as resulting in patient serious injury or death.

From 1/1/2023 through 4/11, FDA says, Getinge initiated eight recalls for the Cardiohelp system, with one being classified as Class 1. In the last 12 months, the agency has received 246 medical device reports, with 33 resulting in patient serious injury or death.

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