The US Food and Drug Administration (FDA) has classified the recall of Boston Scientific’s Accolade pacemaker devices as serious and may cause injury or death.
In December last year, Boston Scientific issued a voluntary notice to all customers, alerting them about the issues with certain Accolade, Proponent, Essentio.
The list also includes Altrua 2 dual-chamber (DR) standard life (SL) and DR extended life (EL) pacemakers, and Visionist and Valitude cardiac resynchronisation therapy pacemakers (CRT-Ps).
The Accolade family of pacemakers are designed to treat slow heart rhythms, also known as bradyarrhythmias by providing dual-chamber and adaptive rate pacing.
Boston Scientific has recalled the devices after noticing that a subset of Accolade pacemakers could permanently enter Safety Mode.
The problem was due to a manufacturing defect that caused the battery to underpower the system, which made the pacemaker fail to regulate heart rhythm and rate.
Safety Mode feature activates during critical device component failures and is triggered when the device experiences three power-on resets within 48 hours due to battery issues.
Once activated, Safety Mode cannot be reversed, limiting the device to unipolar sensing and pacing, which could lead to serious injury or death.
Devices in the Accolade family and CRT-Ps are more likely to enter Safety Mode during remote data collection or other high-powered operations.
If a device enters Safety Mode, it must be removed and replaced to prevent adverse health consequences, such as bradycardia, syncope, and death.
FDA said the recall has been linked to 832 reported injuries and two deaths and the company’s recall ensures patient safety and device reliability.
Also, the agency is working with the company to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed.
FDA, in its statement, said: “The FDA will continue working with Boston Scientific to help ensure that patients, caregivers, and providers are aware of the issue, evaluate information to better understand the issue and to identify additional mitigation strategies as needed.
“The FDA will continue to monitor information about device performance including medical device reports. The FDA will keep the public informed as new information becomes available.”
