HIGH

Boston Scientific Recalls ESSENTIO DR EL MRI Pacemaker Due to Software Issue

Boston Scientific recalled 190,088 ESSENTIO DR EL MRI Pacemakers on August 20, 2025. A software issue may prevent proper device operation in ambulatory settings. Patients must stop using the device immediately and follow recall 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 recalled device is the ESSENTIO DR EL MRI Pacemaker, model number L131. It affects serial numbers ranging from 102068 to 102124. The pacemaker was distributed worldwide.

The Hazard

The pacemaker may enter Safety Mode due to high battery impedance, potentially affecting its operation. This poses a serious risk to patients relying on the device.

Reported Incidents

There are no reported incidents or injuries associated with this recall at this time. However, the hazard classification is deemed high.

What to Do

Patients should stop using the pacemaker immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions and guidance.

Contact Information

For more information, call Boston Scientific Corporation at 1-800-XXX-XXXX or visit their website. Additional details are available on the FDA recall page.

Key Facts

  • Recall initiated on August 20, 2025
  • 190,088 units affected worldwide
  • Potential software malfunction in ambulatory settings
  • Patients advised to stop using the device immediately
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 00802526559266
Serial Numbers: 102068
102071
102072
102074
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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