UPDATED Jan. 12, 2018, with comment from Edwards.
The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve is crimped to Certitude’s balloon before either transapical or transaortic insertion into the body.
The recall, of some 1,730 devices from lots made between Nov. 22, 2016, and July 10 of last year, is due to a molding overflow defect in the button valve within Certitude’s loader, according to the federal safety watchdog. The risk is that the overflow material could detach and embolize into the patient.
Edwards warned customers of the issue last July, asking them to check their inventory for Certitude systems affected by the recall and return any found to the Irvine, Calif.-based company, the FDA said.
Calling the issue an “old recall” that was resolved without incident more than six months ago, a company spokeswoman told TCTMD that the transapical approach represents “very low, single-digit percentage of TAVR procedures.”
“All potentially affected inventory was swapped out without disruption, and there were no patient safety issues and no customer complaints,” the spokeswoman said.