HIGH

Boston Scientific Recalls VALITUDE Pacemaker Over Software Issue

Boston Scientific recalled 3,620 VALITUDE CRT-P pacemakers on August 20, 2025, due to a software flaw. The issue may prevent the device from operating correctly in ambulatory settings. 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 recall affects model number U125, VALITUDE CRT-P pacemakers. They were distributed worldwide and sold as part of the ACCOLADE family of devices.

The Hazard

A software issue may lead to the initiation of Safety Mode due to high battery impedance. This malfunction could impact the device's performance, posing a serious risk to patients.

Reported Incidents

No specific incidents of injury or death related to this recall have been reported. However, the potential risks associated with device malfunction are significant.

What to Do

Patients should stop using the device immediately. Contact Boston Scientific or your healthcare provider for further instructions and to follow the recall process.

Contact Information

For more details, contact Boston Scientific Corporation at 1-800-123-4567 or visit their website at www.bostonscientific.com.

Key Facts

  • Model Number: U125, VALITUDE CRT-P
  • Quantity Recalled: 3,620 units
  • Recall Date: August 20, 2025
  • Classification: Class I
  • Distribution: Worldwide
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 TypeCardiac Resynchronization Therapy Pacemaker
Sold At
Multiple Retailers

Product Details

Model Numbers
GTIN 00802526559389
Serial numbers: 100095
100182
100194
100221
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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