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

Recall Z-1747-2014 — Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation of the biliary ducts

U.S. FDA — Device Enforcement · United States · 2014-03-31 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1747-2014
Date of alert: 2014-03-31
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: NEO METRICS, INC.
Product category: device
Product type: Devices

Reported risk: Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently than anticipated. There have been no reports of illness or injury.

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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