ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps)
This market action has been updated to include new information regarding the software correction, actions for healthcare professionals and inclusion of all CRT-P and dual-chamber extended life (DR-EL) devices. These updates follow on from the previous web statements published in September 2025 and December 2024.
Boston Scientific is conducting a Product Correction and Product Alert for ACCOLADE and VISIONIST pacemakers.
As previously communicated in December 2024, Boston Scientific have advised that a subset of ACCOLADE single chamber (SR), dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST cardiac resynchronization therapy pacemakers (CRT-Ps) have an increased risk of permanently entering Safety Mode which has limited functionality.
Boston Scientific is now notifying healthcare professionals and patients that a software patch is available. This software patch mitigates the risk of devices entering Safety Mode and corrects the unintended behaviours identified that may occur with the previous software patch.
Product details
| Product Name | Model Number | ARTG | Use-by-date |
|---|---|---|---|
| ACCOLADE SR SL MRI | L310 | 400400 | 30 June 2025 |
| ACCOLADE DR SL MRI | L311 | 400399 | 30 June 2025 |
| ACCOLADE DR EL MRI | L331 | 400396 | All |
| VISIONIST CRT-P EL | U225 | 400403 | All |
| U226 | 400404 | All | |
| VISIONIST CRT-P EL MRI | U228 | 400405 | All |
What is the update?
A software update is available to mitigate the previously reported risk of devices permanently entering Safety Mode outside of the clinic during normal, higher-power operations and to correct the unintended behaviours with the previous software patch released in September 2025.
The risk of devices permanently entering Safety Mode has been associated with the pacemaker failing to adequately regulate the heart’s rhythm and rate in some patients.
In addition to the unintended behaviours previously described, Boston Scientific has identified a third unintended behaviour of Model 3869 v2.04. Under specific circumstances, the battery test to determine battery status and longevity time remaining can become frozen until the next programmer interrogation.
The market action has been expanded to cover all ACCOLADE CRT-P and dual-chamber extended life (DR-EL) devices, irrespective of their use‑by date, as some devices may not achieve projected longevity.
What are the risks of entering Safety Mode?
Risks associated with this problem occurring include:
- Device replacement/surgery being required.
- Loss or pause of pacing activity that may result in death or serious injury in some patients not sufficiently treated by Safety Mode.
- Muscle stimulation.
- Heart failure.
What should patients do?
- Continue to have your device monitored, either remotely or through your existing in-office follow-up schedule.
- If monitoring indicates your device has entered Safety Mode, immediately contact your treating clinician for a review and to discuss management options.
- Also consult with your treating clinician if you:
- have new or worsening symptoms such as light-headedness, chest pain, shortness of breath, palpitations, dizziness or loss of consciousness
- have any questions about your device potentially entering Safety Mode or
- to determine the remaining battery life and whether or not the problem may affect you.
- Should you be experiencing symptoms and unable to contact your clinician we recommend attending your nearest healthcare facility for assessment.
What should health professionals do?
- Update LATITUDE Model 3300 programmers with Model 3869 v2.05 software. If you have concerns or need assistance to upload the software update, contact your local Boston Scientific sales representative or call Technical Services (02 8063 8299) to arrange for your programmer’s software to be upgraded.
- Timeframe to update pacemaker software in-clinic:
- For patients at risk of harm due to Safety Mode and who have not already received Model 3869 v2.04: If longevity remaining is four (4) years or less OR will reach four (4) years or less before the next scheduled follow-up, promptly schedule an in-person follow-up.
- For all other patients: Schedule the next follow-up in-person at the frequency described in the Instructions for Use (IFU).
- During the in-person follow-up, interrogate the device using a Model 3300 LATITUDE programmer installed with Model 3869 v2.05 software.
- Replace the device if it enters Safety Mode.
- If the device experiences a Code-1003 alert, contact Technical Services for guidance.
- Monitor patients for symptoms indicating device performance problems, such as light-headedness or loss of consciousness.
Detailed information can be found in the customer letter supplied to clinicians who have implanted this device.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.