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FDA designates recall of transcatheter heart valve system as class 1

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The FDA has designated Edwards Lifesciences’ product recall of a transcatheter heart valve delivery system as a class 1 recall, the most serious kind. The recall affects 1,585 systems manufactured and distributed since Jan. 23.

Burst balloons during transcatheter heart valve implantation procedures using the system (Sapien 3 Ultra), used to treat patients with severe, symptomatic aortic stenosis, may result in difficulty when retrieving the valve and withdrawing the system from the patient, according to a MedWatch report from the FDA. This issue may lead to bleeding, vascular injury or surgical intervention.

Since the field corrective action was initiated by Edwards Lifesciences in July, there have been 17 injuries and one death reported, according to the report.

Edwards Lifesciences distributed a notice to customers on July 9 alerting them of specific recommendations and instructions to potentially prevent issues. Customers were instructed to slowly and continuously inflate the balloon when deploying the valve, according to the report. Instructions were also given in the event of a balloon burst.