FDA Designates Boston Scientific Pacemaker Recall as Class 1

The FDA has designated Boston Scientific’s June 3 recall of its Ingenio pacemakers and certain models of its cardiac resynchronization therapy pacemakers (CRT-Ps) to be Class 1, the most serious type, because the devices may cause serious injuries or death.

The pacemakers, which are used in patients who have low heart rates or moderate-to-severe heart failure, were manufactured between September 2011 and December 2018, and distributed between Nov. 1, 2011, and Aug. 1, 2020. The company announced the recall of the 48,000 devices on June 3.

There have been 65 reported incidents, including three injuries that required patients to receive temporary external pacing, but no deaths, the FDA said.