HIGH

Boston Scientific Recalls ACCOLADE SR SL Pacemakers Over Software Issue

Boston Scientific recalled 16,077 ACCOLADE SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent the device from entering Safety Mode in high battery impedance states. Patients must stop using the device immediately and follow manufacturer's instructions.

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 ACCOLADE SR SL pacemakers, model L300. These devices were distributed worldwide.

The Hazard

The software issue may prevent the initiation of Safety Mode during high battery impedance states. This situation poses a serious risk as it can affect the device's functionality in ambulatory settings.

Reported Incidents

No specific incidents have been reported, but the potential for serious complications exists due to the software failure.

What to Do

Patients and healthcare providers should stop using the device immediately. They must contact Boston Scientific Corporation or their healthcare provider for further instructions.

Contact Information

For more information, visit the Boston Scientific website or call their customer service. Recall instructions are also available in the notification letters sent to users.

Key Facts

  • Recall date: August 20, 2025
  • Report date: October 22, 2025
  • Quantity recalled: 16,077 units
  • Affected models include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, VALITUDE
View Original Recall on FDA - Medical Devices

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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 00802526558900
Serial Numbers: 464190
464192
464197
464228
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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