HIGH

Boston Scientific Recalls ESSENTIO DR SL MRI Pacemaker Due to Software Risk

Boston Scientific recalled 223,163 ESSENTIO DR SL MRI pacemakers on August 20, 2025. The recall addresses a software issue that could prevent the device from functioning properly in certain conditions. Users should stop using the device immediately and follow the manufacturer’s 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 model number is L111, part of the ACCOLADE family of devices. It includes ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2 dual chamber pacemakers, and VISIONIST and VALITUDE CRT-Ps. These devices were distributed globally.

The Hazard

The software issue may prevent the initiation of Safety Mode in an ambulatory setting due to high battery impedance. This situation poses a significant risk to patients relying on these devices.

Reported Incidents

No specific incidents or injuries have been reported in connection with this recall. The recall is classified as Class I, indicating a high risk.

What to Do

Patients and healthcare providers should stop using the ESSENTIO DR SL MRI pacemaker immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.

Contact Information

For more information, visit the Boston Scientific website or call the customer service line. Additional details are available at the FDA’s recall notice: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0095-2026.

Key Facts

  • Model Number: L111
  • Quantity recalled: 223,163 units
  • Classification: Class I
  • Global distribution
  • Contact: Boston Scientific
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 00802526559228
Serial numbers: 103410
200337
200359
200704
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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