HIGH

Boston Scientific Recalls Pacemakers Due to Software Hazard

Boston Scientific recalled 41,191 pacemakers on August 20, 2025, due to a software issue that may prevent proper safety functions. The recall affects several models in the ACCOLADE and VISIONIST families of devices. Patients should stop using the devices immediately and follow manufacturer 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 recall includes model number U228, VISIONIST CRT-P EL MRI pacemakers. The affected devices were distributed worldwide and are part of the ACCOLADE family of devices.

The Hazard

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

Reported Incidents

There have been no reported injuries or deaths associated with this recall. Nonetheless, the potential for serious health complications exists.

What to Do

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

Contact Information

For more information, call Boston Scientific Corporation or visit their website. Patients can also refer to the FDA recall notice at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0105-2026.

Key Facts

  • 41,191 units recalled
  • Class I recall - highest risk
  • Software issue affects several pacemaker models
  • Patients should stop using devices 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 00802526559471
Serial numbers: 726570
728246
728341
728391
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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