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

Recall Z-1017-2013 — Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W. Intended to facilitate catheter placement and exchange during procedures in the aorta.

U.S. FDA — Device Enforcement · United States · 2013-03-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1017-2013
Date of alert
2013-03-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Inc. Cardiac Rhythm Disease Management
Product category
device
Product type
Devices
Reported risk: Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.
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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