Boston Scientific, a global leader in medical technology, has issued a formal correction for its ACCOLADE™ series of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) this week. While the update is not a full product recall, it outlines specific adjustments for certain device models to ensure consistent performance for patients relying on these life-sustaining tools.
What Is the ACCOLADE Correction?
The correction addresses a rare software-related issue affecting fewer than 0.1% of distributed ACCOLADE devices. The glitch may cause unexpected battery drain when the device is programmed to certain high-output pacing modes for extended periods, potentially shortening the time between scheduled device replacements.
Which Devices Are Affected?
The correction applies to specific batches of ACCOLADE devices manufactured between January 2022 and March 2023, distributed across the U.S., European Union, and select Asian markets. Affected models include:
- ACCOLADE™ MRI Pacemakers (model numbers L100, L110, L120)
- ACCOLADE™ CRT-Ps (model numbers L200, L210, L220)
Patients can check their device identification card or contact their cardiology team to confirm if their device is part of the affected batch.
Is This a Product Recall?
Importantly, this is a device correction, not a full product recall. Boston Scientific confirms no patient injuries or deaths have been linked to the issue to date, and most affected devices remain safe for continued use. The correction requires either a 15-minute in-office firmware update for eligible devices, or adjusted remote monitoring protocols for patients who cannot undergo the update due to health constraints.
Next Steps for Patients
- Verify your device status with your cardiologist or by checking your device registration details.
- Schedule a free, 15-minute in-office update if your device is eligible.
- Monitor for symptoms like unexplained dizziness, fatigue, or irregular heartbeat, and report any concerns to your care team immediately.
- Enroll in Boston Scientific’s remote monitoring program to receive real-time alerts about device performance.
Guidance for Healthcare Providers
- Review patient device registries to identify affected ACCOLADE models in your care within 14 days.
- Notify eligible patients of the correction and next steps within 30 days of the announcement.
- Administer free firmware updates during routine follow-up visits; no additional supplies are required.
- Update patient medical records to document the correction and any device adjustments made.
Why This Update Matters
Pacemakers and CRT-Ps support heart function for millions of people with arrhythmias, heart failure, and other cardiac conditions. Proactive corrections like this one are a standard part of medical device safety protocols, ensuring long-term reliability for patients who depend on these devices daily. Boston Scientific has confirmed it is coordinating with the FDA and international regulatory bodies to ensure all affected patients receive timely support.
Stay Informed
Medical device corrections are routine, but they can cause confusion for patients and caregivers. If you have questions about your ACCOLADE pacemaker or CRT-P, reach out to your cardiology team first — they have the most up-to-date information for your specific case. We will update this post with new details as they become available from Boston Scientific and regulatory agencies.
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