This page shares information for health care providers on ongoing heart rhythm device advisories and recalls that affect patients in BC.
When Health Canada issues a heart rhythm device advisory or recall, Cardiac Services BC provides support in the identification of impacted patients, establishes a provincial management approach and provides materials to support physicians with communicating advisory or recall information—and next steps—to patients, families and caregivers.
DISCLAIMER: Apart from official CSBC guidance and support documents, CSBC does not necessarily endorse the views expressed in any external documents.
December 2025 - Boston Scientific RELIANCE ePTFE defibrillation leads with an increased potential to exhibit a gradual rise in low-voltage shock impedance
During post-market surveillance, Boston Scientific has observed a pattern of gradually rising
low-voltage shock impedance (LVSI) measurements in association with expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE™ defibrillation leads manufactured between 2002 and 2021 that are no longer available for distribution.
November 2025 - Urgent Medical Device Safety Notice: Boston Scientific ACCOLADE Family Expansion of Pacemaker & CRT-P devices
As of October 29, 2025, the enhanced software Boston Scientific intended to detect high battery impedance and prevent initiation of Safety Mode in ACCOLADE™ devices in an ambulatory setting is available in Canada. When a pacemaker receives this enhanced software, prophylactic replacement is no longer recommended for patients at risk of harm due to the non-programmable parameters in Safety Mode.
Boston Scientific is expanding these recommendations to all device types in the ACCOLADE family (includes ACCOLADE™, PROPONENT™, ESSENTIO™, and ALTRUA™ 2, VISIONIST™ and VALITUDE™) with a use-by-date on or before 30 June 2025.
November, 2025 - Advisory: Medtronic Aurora EV-ICD – Potential for Suspension of Dynamic Sensing Algorithm
A potential delay in the time to high-voltage (HV) therapy may occur with Medtronic Aurora EV-ICD devices (DVEA3E4 and DVEX3E4) if a rare, specific combination of events were to occur. This delay in HV therapy may result in reduction of defibrillation efficacy.
September 2025 - Boston Scientific RELIANCE ePTFE defibrillation leads with an increased potential to exhibit a gradual rise in low-voltage shock impedance
During post-market surveillance, Boston Scientific (BSC) has observed a pattern of gradually rising low-voltage shock impedance (LVSI) measurements in association with expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE™ defibrillation leads manufactured between 2002 and 2021 that are no longer available for distribution.
August 2025 - Advisory: ACCOLADE family pacemakers and CRT-Ps with an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to high battery impedance
A subset of devices from the ACCOLADE family has an increased potential to initiate Safety Mode during higher-power operations due to latent high battery impedance.
August 2025 - Advisory: Boston Scientific RELIANCE ePTFE defibrillation leads with an increased potential to exhibit a gradual rise in low-voltage shock impedance
During post market surveillance, Boston Scientific (BSC) has observed a pattern of gradually rising low-voltage shock impedance (LVSI) measurements in association with expanded polytetrafluoroethylene (ePTFE) coated single coil (SC) and dual coil (DC) RELIANCE™ defibrillation leads manufactured between 2002 and 2021 that are no longer available for distribution.
February 2025 - Advisory: Abbott Medical Device Recall Subset of ASSURITY™ AND ENDURITY™ PACEMAKERS MODELS PM1160, PM1172, PM1272, PM2172, PM2240, PM2272
During post market surveillance, Abbott has observed malfunctions in a subset of the above devices manufactured between August 2019 and June 2020 in a specific manufacturing plant with equipment that is no longer in use. The issue is related to an intermittent incomplete mixing of epoxy, which may result in moisture ingress into the pulse generator header in some devices. This may result in loss of telemetry or communication with the device, loss of pacing, reduced battery longevity, and a shortened Elective Replacement Indication (ERI) to End of Service (EOS) time.
