The Food and Drug Administration issued a notice on Friday classifying its recall of the Boston Scientific Accolade pacemaker devices as the most serious type of recall.
To date, 832 injuries and two deaths tied to the devices have been reported. The recall affects about 13% of Accolade devices manufactured before September 2018.
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The pacemakers treat slow heart rhythms by pacing the upper and lower chambers of the heart and adjusting the pacing rate to meet the body’s needs. Due to a manufacturing issue with the battery cathode, the pacemakers might enter safety mode under certain conditions, and as a result may not properly regulate the heart’s rhythm and rate, according to the FDA.
Boston Scientific sent its clinician customers a letter regarding this issue in December. It recommended replacing the pacemaker immediately if it enters safety mode, but also replacing pacemakers in non-emergency situations.
The FDA advised healthcare providers to monitor patients with Accolade pacemakers through remote or in-office visits to determine if the devices are in safety mode.
There were 1,059 medical device recalls in 2024, which is a four-year high, according to a Feb. 14 report on product recalls by the risk management firm Sedgwick. Nearly 100 Class I FDA recalls were made last year, which is the highest in more than 15 years.
