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

Recall Z-0342-2016 — Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.

U.S. FDA — Device Enforcement · United States · 2015-11-09 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0342-2016
Date of alert
2015-11-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc.
Product category
device
Product type
Devices
Reported risk: Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term battery performance. The root cause is unexpected high battery impedance.
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.

Related

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.