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# Class 1 Recall on Boston Scientific Pacemakers
- URL: https://www.fdaweb.com/class-1-recall-on-boston-scientific-pacemakers/
- Published: 2021-08-06T12:00:00.000Z
- Updated: 2026-09-14T17:09:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149887

FDA has classified as Class 1 a Boston Scientific recall of its 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, a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/boston-scientific-recalls-ingenio-family-pacemakers-and-crt-ps-due-risk-incorrect-transition-safety?ref=fdaweb.com) says. “However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions,” it says. “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 injuries, the notice says. There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing.