The Recall Desk
HighFDA (Devices)·Z-1747-2014·Announced 2014-06-18

Neo Metrics Recalls NovaGold Guidewires Due to Tip Uncoiling Risk

Neo Metrics, Inc. is recalling NovaGold High Performance Guidewires because the tip may uncoil or detach more frequently than anticipated. No illnesses or injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Neo Metrics, Inc. is recalling the Boston Scientific NovaGold High Performance Guidewire. The recall is being conducted because the device tip may uncoil and/or detach more frequently than anticipated. The affected product is a medical device intended for use in selective cannulation of the biliary ducts and to aid in the placement of diagnostic and therapeutic devices during endoscopic procedures.

The recall involves 1,256 boxes, with two wires per box. The affected lot codes are MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, and MO27899. The product was distributed worldwide, including in the United States and in Austria, Belgium, Germany, Spain, France, Great Britain, Italy, the Netherlands, and Sweden.

According to the source text, there have been no reports of illness or injury associated with this recall. Healthcare providers and facilities should check their inventory for the specific lot codes listed and follow the instructions provided by the recalling firm.

The recalled product

Product
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 o
Manufacturer
NEO METRICS, INC.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • MO26343
  • MO26345
  • MO26724
  • MO27402
  • MO26342
  • MO26344
  • MO26731
  • MO27401
  • MO27660
  • MO27901
  • MO27659
  • MO27820
  • MO27899

Distribution

Distribution scope not specified by the agency.