HIGH

Boston Scientific Recalls Pacemakers Over Software Safety Risk

Boston Scientific recalled 12,326 pacemakers on August 20, 2025 due to a software issue. The defect can prevent the device from entering Safety Mode, posing a high risk of malfunction. Patients should stop using the devices and follow recall procedures immediately.

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 the U225 VISIONIST CRT-P EL pacemaker and other models in the ACCOLADE family. Devices were distributed worldwide. The affected models include serial numbers ranging from 709683 to 709912.

The Hazard

The software flaw can prevent the device from entering Safety Mode due to a high battery impedance state. This malfunction increases the risk of device failure in an ambulatory setting.

Reported Incidents

No specific incidents or injuries have been reported due to this software issue. The recall was initiated as a precaution to prevent potential risks.

What to Do

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

Contact Information

For more details, call Boston Scientific at 1-800-XXX-XXXX or visit their website at www.bostonscientific.com.

Key Facts

  • Recall date: August 20, 2025
  • Status: Active
  • Classification: Class I
  • Quantity: 12,326 units
  • Worldwide distribution
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 00802526559426
Serial numbers: 709683
709711
709737
709778
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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