FDA (Devices) recall action 95969
The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
The agency’s own wording, quoted from the enforcement report.
Boston Scientific is recalling certain ESSENTIO DR Pacemakers manufactured before September 2018 due to latent battery impedance that may cause Safety Mode malfunction during normal operations.
Boston Scientific ALTRUA 2 DR Pacemakers may unexpectedly enter Safety Mode during normal operation due to high battery impedance, potentially affecting device functionality.
Boston Scientific is recalling ACCOLADE DR Pacemakers built before September 2018 due to risk of unintended Safety Mode activation caused by battery impedance issues. The devices may enter Safety Mode during normal telemetry operations.
Certain VISIONIST CRT-P pacemakers with latent high battery impedance may initiate Safety Mode unexpectedly during normal operations. Manufactured before September 2018, 156,329 units were distributed worldwide.
Boston Scientific is recalling certain PROPONENT DR pacemakers built before September 2018 due to latent battery impedance that could cause unexpected Safety Mode initiation during normal operation.
Boston Scientific's ACCOLADE Family pacemakers, including VALITUDE CRT-P models, are recalled due to battery impedance defects that could trigger unintended Safety Mode during normal operation.