A recent Cardiovascular Business article discussed the FDA recall of 48,000 heart devices manufactured by Boston Scientific. The reason for the recall is the potential for an incorrect transition into safety mode. The affected devices are INGENIO pacemakers and cardiac resynchronization therapy pacemakers. “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.”
The recall is classified as Class I, which means the issue could lead to serious injury or death. Though 65 incidents and three injuries have been reported, no deaths have occurred.