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

Recall Z-1813-2014 — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA. Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire fa

U.S. FDA — Device Enforcement · United States · 2014-05-28 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1813-2014
Date of alert: 2014-05-28
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Nitinol Devices and Components, Inc.
Product category: device
Product type: Devices

Reported risk: Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity 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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