Reported Jun 18, 2014 · Terminated

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and…

Neo Metrics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: NEO METRICS, INC. · 2605 Fernbrook Ln N Ste J · Plymouth, MN · 55447-4756

Is this the product you have?

  • 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 including the common bile, pancreatic, cystic, right and left hepatic ducts, and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.
Lot codes and dates
    • MO26343
    • MO26345
    • MO26724
    • MO27402
    • MO26342
    • MO26344
    • MO26731
    • MO27401
    • MO27660
    • MO27901
    • MO27659
    • MO27820
    • MO27899
Amount recalled
1256 boxes ( 2 wires/box)

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 16, 2015 · Data as of Sep 19, 6:15 PM UTC

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