The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA approved the Sapien 3 Ultra system (alongside Sapien 3 and Medtronic’s Evolut R and Evolut PRO devices) for the management of aortic stenosis in low-risk patients.

As previously stated by Edwards Lifesciences, the burst balloons with the Sapien 3 Ultra system have resulted in significant difficulty retrieving the valve into the catheter and withdrawing the system from the patient; this may cause vascular injury, bleeding, or surgical intervention. The FDA reports that the use of affected product “may cause serious adverse health consequences, including death”. It adds that 17 injuries and one death were reported at the time when Edwards initiated the Field Corrective Action in July 2019.

In its recall notice, the FDA outlines the following:

  • Recalled product: Sapien 3 Ultra delivery system
  • Lot numbers: All lots
  • Manufacturing dates: 23 January 2018–16 July 2019
  • Distribution dates: 3 January 2019–present
  • Devices recalled in the USA: 1,585
  • Date initiated by firm: 8 July 2019
  • Who may be affected: patients in the USA who had a TAVI procedure using the Edwards Sapien 3 Ultra transcatheter heart system, starting 3 January 2019; physicians in the USA who used the Sapien 3 Ultra transcatheter heart system starting 3 January 2019.

Furthermore, under the heading “what to do”, the FDA outlines the recommendations listed in Edwards Lifesciences’ recent urgent safety notice for the Sapien 3 Ultra system (published in July 2019).

Of note, when Boston Scientific encountered problems with the delivery system of its TAVI Lotus Edge in 2017, it took Lotus Edge off the market. After several delays, the device came back onto the European market this year and was also FDA approved for the US market.