The Food and Drug Administration (FDA) has announced a recall of the INGENIO pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps; Boston Scientific) due to the risk of incorrect transition to safety mode.
Boston Scientific INGENIO pacemakers and CRT-Ps are devices used to treat certain symptomatic conduction disorders and moderate to severe heart failure. The company is recalling INGENIO pacemakers and CRT-Ps due to the risk of incorrect transition to safety mode. Safety mode is intended to provide backup if the device is faulty. However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device incorrectly goes into safety mode, the device cannot be reprogrammed and must be replaced.
The use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury, worsening of heart failure, and death.
There have been 65 reported incidents related to this issue, including 3 injuries which required patients to receive temporary external pacing. There have been no reports of death. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. The manufacturer does not recommend preventive replacement for all affected devices. However, if a device incorrectly enters safety mode, a replacement should be scheduled. In addition, shared decision-making may support early device replacement to prevent unintended outcomes when considering patient-specific factors, including underlying health issues, pacemaker dependence, or problems with pacing.
Food and Drug Administration (FDA). Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode [medical device recall]. August 8, 2021. Available at: click here. Accessed August 9, 2021.