HIGH

Boston Scientific Recalls Pacemakers Due to Software Malfunction

Boston Scientific recalled 32,695 pacemakers on August 20, 2025. The recall affects multiple models due to software that may prevent initiation of Safety Mode. This defect poses a high hazard level to patients who rely on these devices.

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 includes ACCOLADE DR SL (Model L301) and other models from the ACCOLADE family. These devices were distributed worldwide, with a total of 32,695 units recalled.

The Hazard

The software issue may prevent the pacemakers from entering Safety Mode during high battery impedance conditions. This can lead to serious health risks for patients relying on these devices.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. However, the potential for serious health implications is significant.

What to Do

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

Contact Information

For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0080-2026.

Key Facts

  • Recall date: August 20, 2025
  • Report date: October 22, 2025
  • Quantity recalled: 32,695 units
  • Affected devices include multiple pacemaker models
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 00802526558924
Serial Numbers: 100056
100092
100111
100120
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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