Boston Scientific ACCOLADE Pacemaker Update: What Patients Need to Know

Boston Scientific recently issued an updated safety notice for its ACCOLADE family of pacemakers and CRT-P devices. The Model 3869 v2.04 software aims to prevent devices from entering Safety Mode due to high battery impedance, a condition that can affect proper heart pacing. While this update improves device safety, some unintended behaviors have been identified, making patient monitoring and awareness critical.

What Is Happening With ACCOLADE Pacemakers?

ACCOLADE pacemakers—including PROPONENT™, ESSENTIO™, ALTRUA™, VISIONIST™, and VALITUDE™ devices—use lithium batteries that can, over time, develop high impedance. This may cause the device to enter Safety Mode, a backup pacing setting that may not provide adequate therapy for patients who rely on continuous cardiac support.

The new software introduces:

1. Telemetry-activated battery tests triggering Code-1003 alerts if the battery cannot sustain expected longevity.

2. Disabling of wandless ZIP telemetry to prevent unintended Safety Mode initiation in ambulatory patients.

However, Boston Scientific has noted two possible issues:

• Low-power automatic telemetry may still inadvertently trigger Safety Mode.

• Magnets may cause false positive alerts, disabling wandless telemetry and limiting remote monitoring.

Why This Matters

Safety Mode provides backup pacing but may not meet every patient’s needs. Serious complications—including presyncope, syncope, falls, and deaths—have occurred when devices entered Safety Mode unexpectedly. Patients nearing the end of battery life (≤4 years remaining) are at highest risk.

Boston Scientific recommends continued software installation, regular follow-ups, and close remote monitoring. Prophylactic replacement is generally not recommended, except in high-risk scenarios.

KBD Attorneys’ Role: Protecting Patients and Families

At Ketterer, Browne & Davani, LLC,  (KBD Attorneys), we recognize the danger posed by defective medical devices, including pacemakers. Families affected by Safety Mode complications, alerts, or failed remote monitoring may be entitled to legal recourse. Our attorneys have helped clients navigate cases involving defective medical devices, ensuring patient safety and accountability.

If you or a loved one experienced complications with an ACCOLADE pacemaker, it’s important to consult an experienced product liability attorney.

Related KBD Resources

At KBD we have been writing about issues with these pacemakers as well as other defective medical devices. Read more of our blog for more information:

• Accolade Pacemaker: Accolade, Proponent, Essentio, Altrua, Visionist, and Valitude Pacemaker Recall –

• Boston Scientific Recall – Accolade Pacemaker Recall

• Boston Scientific Accolade Pacemaker Software Update

What Patients Should Do

1. Verify device software: Contact your cardiologist to confirm Model 3869 v2.04 is installed.

2. Monitor alerts: Pay attention to Code-1003 warnings or LATITUDE notifications.

3. Report issues: Notify your doctor and Boston Scientific Technical Services. Adverse events can also be reported to FDA MedWatch.

4. Seek legal guidance: If device malfunction caused harm, a medical device attorney can explain your options.

Boston Scientific’s update addresses some high battery impedance risks, but vigilance is still required. At KBD Attorneys, we are dedicated to protecting patients from defective medical devices and ensuring accountability for manufacturers when safety lapses occur. Contact us if your have been harmed by this product or any other defective medical device.

Urgent Medical Device Correction: 

Updatehttps://www.bostonscientific.com/content/dam/bostonscientific/quality/documents/Recent%20Product%20Advisories/2025-Sep_BSC_ACCOLADE_SafetyMode_SMR5_Letter2a_PhysLtr_US_FINAL.pdf

Paient letter: 

https://www.bostonscientific.com/content/dam/bostonscientific/quality/documents/Recent%20Product%20Advisories/2025_Sept_BSC_ACCOLADE_HiBattImpedance_PtLtr.pdf