In a May 14 news release, the medical device company said it will “immediately pause promotional activities of the Cardiohelp System and Cardiosave [Intra-Aortic Balloon Pump] in the U.S. until outstanding actions related to quality improvements have been addressed and approved.”
The decision is a response to the FDA’s May 8 letter to providers, which said the agency has received 48 reports of deaths and serious injuries connected to Getinge balloon pumps, HLS sets and Cardiohelp systems. After numerous recalls and corrections, the FDA said it is still receiving reports of device issues.
As Getinge works with the FDA, the company will limit sales of these hardware products to customers who do not have alternatives.
Getinge’s market share for the affected products is more than 60%, according to the release.
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