The FDA has announced that Boston Scientific is recalling 48,000 INGENIO pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps).
The recall is due to potential issues when the devices transition to safety mode.
“Safety mode is intended to provide backup if the device is faulty,” according to the FDA. “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.”
Using an affected device can lead to “serious adverse health consequences,” the agency added. Early device replacement, heart failure and death are all listed as potential outcomes.
This is a Class I recall, which means the issue can lead to serious injury or death. While 65 incidents and three injuries have been reported to the FDA, there have been no deaths at this time.
When Boston Scientific first initiated the recall on June 3, all affected customers were sent an advisory detailing the issue. To increase awareness, information was also added to the electronic health record of every patient who may encounter this problem.
Customers were asked to schedule a replacement of any device that enters safety mode incorrectly. A preventive replacement is not recommended in most instances.
Model numbers included in this recall are J174, J177, K174, K184 and K187. The devices were distributed to customers from November 2011 to August 2020. More information is available here.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.