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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

Boston Scientific Corporation 2025-10-22 Health critical FDA
Health · FDA · Recall #FDA-Z-0099-2026

Model Number S702, ALTRUA 2 DR SL Pacemaker Recall

Issued October 22, 2025 · Boston Scientific Corporation

In October 2025, Boston Scientific Corporation recalled the Model Number S702, ALTRUA 2 DR SL Pacemaker, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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

  1. 1 Stop using Model Number S702, ALTRUA 2 DR SL Pacemaker right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
Boston Scientific Corporation
Category
Health
Recall date
October 22, 2025
Units affected
Not reported
Sold at
Worldwide
Recall number
FDA-Z-0099-2026
Made in
United States
Issuing agency
FDA

In context

  • Boston Scientific Corporation has 35 recalls in our database, including 13 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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