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

Recall Z-2000-2021 — Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

U.S. FDA — Device Enforcement · United States · 2021-06-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2000-2021
Date of alert
2021-06-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Boston Scientific Corporation
Product category
device
Product type
Devices
Reported risk: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the battery and associated progression of displayed battery depletion indicators.
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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