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

Recall Z-0310-2017 — X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-0601-300V10 103-0602-

U.S. FDA — Device Enforcement · United States · 2016-10-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0310-2017
Date of alert
2016-10-05
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Product category
device
Product type
Devices
Reported risk: Delamination and detachment of the PTFE (polytetrafluoroethylene) coating material may lead to PTFE coating in the blood stream.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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