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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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.
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