HIGH

Boston Scientific Recalls PROPONENT SR SL Pacemakers Over Software Issue

Boston Scientific recalled 1,380 PROPONENT SR SL pacemakers on August 20, 2025. The recall addresses a software issue that may prevent safety mode activation in ambulatory settings. Healthcare providers and patients must stop using the devices 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 the PROPONENT SR SL model (GTIN 00802526559020) along with several serial numbers. These devices were distributed worldwide.

The Hazard

A software issue may prevent the initiation of safety mode due to high battery impedance. This failure poses a high risk to patient safety.

Reported Incidents

No specific incidents, injuries, or deaths have been reported related to this recall. However, the potential for severe consequences warrants immediate action.

What to Do

Patients should stop using the recalled pacemakers immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions.

Contact Information

For assistance, call Boston Scientific at their customer service line or visit their website for updates on the recall.

Key Facts

  • Recall date: August 20, 2025
  • Quantity recalled: 1,380 units
  • Affected models include PROPONENT, ACCOLADE, and others
  • Software issue may affect patient safety
  • Immediate action required by users
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 00802526559020
Serial numbers: 722605
722614
722634
722647. GTIN 00802526576362
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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