HIGH

Boston Scientific Recalls ACCOLADE DR EL MRI Pacemakers Over Safety Risk

Boston Scientific recalled 34,180 ACCOLADE DR EL MRI pacemakers on August 20, 2025. The recall addresses a software issue that may prevent proper function in ambulatory settings. Patients should stop using the 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 ACCOLADE DR EL MRI pacemakers, model L331. The devices were distributed worldwide and have been linked to serious safety concerns.

The Hazard

The software issue may prevent the pacemakers from entering Safety Mode due to high battery impedance. This could lead to inadequate cardiac support, posing a high risk to patients.

Reported Incidents

As of now, there are no specific reported incidents or injuries directly linked to this software malfunction. However, the potential for serious health risks remains.

What to Do

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

Contact Information

Patients can reach Boston Scientific at their official website for more information regarding the recall.

Key Facts

  • Recall date: August 20, 2025
  • Quantity recalled: 34,180 units
  • Device affected: ACCOLADE DR EL MRI (Model L331)
  • Potential safety risk due to software issue
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 00802526559006
Serial Numbers: 102138
102172
102192
102209
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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