HIGH

Boston Scientific Recalls Pacemaker Over Software Hazard

Boston Scientific recalled 10,833 units of its L121 ESSENTIO DR EL Pacemaker on August 20, 2025. The recall addresses a software issue that could prevent the device from operating correctly in certain conditions. Patients and healthcare providers must stop using the device 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 recalled model is the L121 ESSENTIO DR EL Pacemaker, part of the ACCOLADE family. Units were distributed worldwide, and the recall affects serial numbers including 100009 to 100328.

The Hazard

The recall addresses a software issue that may prevent the pacemaker from initiating Safety Mode in ambulatory settings due to high battery impedance. This malfunction could lead to critical health risks for patients.

Reported Incidents

No specific incidents, injuries, or deaths are reported at this time. The risk level is classified as high due to potential functional failures.

What to Do

Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions from Boston Scientific and contact their healthcare provider for further guidance.

Contact Information

For more information, contact Boston Scientific Corporation directly or visit their official website. Additional details are available at the FDA recall report.

Key Facts

  • 10,833 units recalled
  • Software hazard in pacemaker
  • High battery impedance state risk
  • Immediate stop-use recommendation
  • Contact Boston Scientific for instructions
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 00802526559242
Serial Numbers: 100009
100026
100029
100030
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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