Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0089-2026 — Model Number L211 PROPONENT DR SL MRI Pacemaker

U.S. FDA — Device Enforcement · United States · 2025-08-20 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0089-2026
Date of alert
2025-08-20
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00802526559105
Reported risk: 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).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.