HIGH

Boston Scientific Recalls Pacemakers Over High Battery Impedance Risk

Boston Scientific recalled 41,009 pacemakers on August 20, 2025, due to a software issue that could trigger Safety Mode. This affects the ACCOLADE family of devices, including the PROPONENT model. Patients should stop using these devices immediately and contact their healthcare provider.

Quick Facts at a Glance

Recall Date
August 20, 2025
Hazard Level
HIGH
Brand
Boston Scientific
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter

Product Details

The recall involves model number L210 PROPONENT SR SL pacemakers. These devices were distributed worldwide.

The Hazard

The recall addresses a software issue that prevents the initiation of Safety Mode in ambulatory settings due to high battery impedance states. This malfunction can lead to serious health risks for patients.

Reported Incidents

No specific incidents or injuries have been reported associated with this recall. The potential for harm exists if the device enters Safety Mode unexpectedly.

What to Do

Patients and healthcare providers should stop using the recalled devices immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.

Contact Information

For more information, call Boston Scientific Corporation or visit their website. Detailed recall instructions are also available in a notification letter.

Key Facts

  • Recall date: August 20, 2025
  • Report date: October 22, 2025
  • Quantity recalled: 41,009 units
  • Affected models include ACCOLADE and PROPONENT
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypePacemaker
Sold At
Multiple Retailers

Product Details

Model Numbers
GTIN 00802526559082
Serial Numbers: 100002
100009
100010
100011
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more