The FDA has issued a class 1 recall of the Sapien 3 Ultra transcathether heart valve delivery system after reports of burst balloons during surgery. As of July, one death and 17 injuries had been reported to the devicemaker.
The FDA said the burst balloons resulted in "significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient."
The burst balloon may result in vascular injury, bleeding or the need for surgery.
Edward Lifesciences, based in Irvine, Calif., previously issued a safety notice about the delivery system to physicians on July 9. After the notice, Health Canada issued a medical device recall. Now the FDA has followed suit.
The devices will still be for sale after the devicemaker places additional warnings and instructions on the label. The devicemaker issued recommendations and instructions for physicians, including inflating the balloon slowly and actions to take if a burst balloon is suspected.
The delivery system is used to implant the Edwards Lifesciences transcatheter heart valve into a patient with aortic valve stenosis, a narrowing of the heart's aortic valve that restricts blood flow.
Class 1 recalls, the most serious, are for products the FDA says could cause serious health problems or death.