FDA: Class I Recall for Burst Balloons With Sapien 3 Ultra Delivery System

A problem with bursting balloons with the Sapien 3 Ultra transcatheter heart valve delivery system (Edwards Lifesciences), previously reported by TCTMD, has now been identified as a class I recall by the US Food and Drug Administration.

The Class I recall, which is the most serious, follows reports of burst balloons during the implantation procedure, which “have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient,” according to the FDA. These may result in vascular injury, bleeding, or the need for surgery.

The company had issued an urgent field safety notice on July 10 that at the time was categorized as a Type I medical device recall by Health Canada. Now the FDA has followed suit, and while the action has been identified as Class I recall by the American regulator, as in Canada, no product is being pulled from the market.

Instead, as part of the field corrective action initiated by Edwards Lifesciences last month, a series of recommendations and instructions to physicians on the use of the Sapien Ultra delivery system have been prescribed. These include directions to inflate the balloon slowly and continuously throughout valve deployment, as well as actions to take if a burst balloon is suspected.

Edwards will add a warning to the Sapien 3 Ultra transcatheter heart valve system instructions for use stating that “failure to use slow, controlled inflation and prescribed nominal inflation volumes may result in balloon rupture, difficulty retrieving the delivery system, and may require subsequent conversion to surgical intervention.”

The FDA recall notice today notes that 17 injuries and one death were reported at the time that Edwards initiated the corrective action in July.