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

Recall Z-0267-2014 — THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target lesion. Medtronic guid

U.S. FDA — Device Enforcement · United States · 2013-10-21 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0267-2014
Date of alert: 2013-10-21
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Medtronic Vascular
Product category: device
Product type: Devices

Reported risk: Potential for PTFE (polytetrafluroethylene) coating to delaminate and detach from Guidewire.

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.

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.

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