HIGH

Boston Scientific Recalls ESSENTIO SR SL MRI Pacemaker Over Safety Software Issue

Boston Scientific recalled 61,700 ESSENTIO SR SL MRI Pacemakers on August 20, 2025, due to a software issue. The software failure can lead to the device entering Safety Mode unexpectedly in high battery impedance situations. Patients must stop using the device immediately and follow recall instructions from 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 recalled product is the ESSENTIO SR SL MRI Pacemaker, model number L110. It was distributed worldwide and includes multiple models from the ACCOLADE family. The recall affects 61,700 units.

The Hazard

The device's software may fail to prevent the initiation of Safety Mode during high battery impedance in ambulatory settings. This software issue presents a high hazard level and could lead to serious health risks for patients.

Reported Incidents

As of now, there are no specific reported incidents or injuries associated with this recall. The potential for failure could pose serious risks if not addressed.

What to Do

Patients and healthcare providers should stop using the device immediately. Contact Boston Scientific Corporation or your healthcare provider for detailed instructions on the recall.

Contact Information

For further assistance, contact Boston Scientific Corporation at 1-800-XXX-XXXX or visit their website. For more information, see the FDA recall notice at the provided URL.

Key Facts

  • Model Number: L110
  • Quantity Recalled: 61,700 units
  • Recall Date: August 20, 2025
  • Hazard Level: High
  • Affected models include ACCOLADE, PROPONENT, ESSENTIO, ALTRUA 2, VISIONIST, VALITUDE
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

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 00802526559204
Serial Numbers: 102163
700197
700207
701035
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more