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

Recall Z-0822-2025 — ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

U.S. FDA — Device Enforcement · United States · 2024-12-12 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0822-2025
Date of alert: 2024-12-12
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00802526559174

Reported risk: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0822-2025 — ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)

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