HIGH

Boston Scientific Recalls ALTRUA 2 Pacemaker Over Safety Software

Boston Scientific recalled 4,841 ALTRUA 2 SR SL pacemakers on August 20, 2025. The recall stems from a software issue that may prevent proper device function in patients. Users should stop using the device 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 recalled product is the ALTRUA 2 SR SL pacemaker, model number S701. It has been distributed worldwide and is classified as Class I.

The Hazard

The recall addresses a software issue that could prevent the initiation of Safety Mode in cases of high battery impedance. This malfunction poses a serious risk to patients relying on these devices.

Reported Incidents

There have been no reported injuries or deaths related to this recall. The software issue represents a high hazard level.

What to Do

Stop using the pacemaker immediately. Contact Boston Scientific Corporation or your healthcare provider for further instructions on how to proceed.

Contact Information

For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0098-2026 or call Boston Scientific Corporation.

Key Facts

  • Recall date: August 20, 2025
  • Class I recall
  • Quantity recalled: 4,841 units
  • Affected models include S701 ALTRUA 2 SR SL pacemaker
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 00802526576492
Serial numbers: 705372. GTIN 00802526559334. Serial numbers: 100002
100003
100004
100005
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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