FDA has designated Boston Scientific’s recall of its Ingenio family of pacemakers as Class I, its most serious level.
The agency’s Class I designation for Ingenio, posted on Aug. 6, said the recall involves 48,000 devices — model Nos. J174, J177, K174, K184 and K187. The pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) in the recall include models such as the Advantio DR EL, Ingenio DR EL and Vitalio DR EL. The manufacturing dates are from September 2011 to December 2018, with distribution from November 1, 2011, to August 1, 2020.
Boston Scientific initiated the recall on June 3 because the pacemakers or cardiac resynchronization therapy pacemakers may incorrectly transition to safety mod. Going into safety mode could create a risk of inappropriate pacing loss due to sensing muscle contractions. Once the pacemaker goes into safety mode, it is not possible to reprogram it.
FDA said there have been 65 reported incidents related to the problem, including three injuries in which a person needed temporary external pacing. There have been no reports of death.
“We initiated the advisory in June 2021 because of the potential for these devices to transition to safety mode during interrogation attempts due to an elevated internal battery impedance that can occur later in device life, requiring early replacement. Manufacturing of these devices was discontinued in 2018, and no devices within this advisory subset are still available for implant,” Boston Scientific said in a statement that a spokesperson shared with MassDevice.
Boston Scientific sent an Important Medical Device Advisory to customers on June 3, in which it said patients would need their pacemakers replaced if they go into safety mode. The company did not recommend preventive replacement but did say that patients and their physicians consider early device replacement in certain circumstances.
Boston Scientific in its statement said: “Device performance can be assessed through regularly scheduled doctor visits and, where available, can be monitored remotely. Healthcare providers will reach out to patients directly if a separate appointment should be made to assess their device.”