Drug Recalls

Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode

Posted on by Editor

Date: 08/10/2021

Product type: Medical Device

Recalled Product

  • Product Names: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL)
  • Product Codes: LWP
  • Model Numbers: J174, J177, K174, K184, and K187
  • Manufacturing Dates: September 2011 to December 2018
  • Distribution Dates: November 1, 2011 to August 1, 2020
  • Devices Recalled in the U.S.: 48,000
  • Date Initiated by Firm: June 3, 2021

US-FDA Link: https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-ingenio-family-pacemakers-and-crt-ps-due-risk-transition-safety-mode