FDA Issues Class I Recall for Certain Boston Scientific Pacemakers

WASHINGTON, D.C. — The Food and Drug Administration has issued a Class I recall for certain Boston Scientific Corp. pacemakers, explaining that they have an increased risk to permanently enter “safety mode,” rendering them unable to properly regulate the heart’s rhythm and rate in some patients.

In a Feb. 21 safety communication, the agency explained that a previous pacemaker recall has been upgraded to a Class I designation, warning that continued use of the devices could cause serious injury or death.

The increased risk of permanently entering safety mode is caused by the device’s battery underpowering the system because …