Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 18, 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 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.
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.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Neo Metrics, INC. recalled Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylen… - a moderate-severity action.
Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylen… was recalled by Neo Metrics, INC. in June 18, 2014. Reason: Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently tha…. Check the official notice for the remedy. Verify recall #Z-1747-2014 with the FDA Devices before acting.
The recall
Neo Metrics, INC. issued this moderate-severity FDA Devices recall-Neo Metrics, Inc. is recalling NovaGold Guidewire because the tip may uncoil and / detach more frequently tha….
- Moderate
- severity level
- Class II
- classification
- June 18, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1747-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1747-2014) was formally reported on June 18, 2014, with the manufacturer initiating the action on March 31, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Neo Metrics, INC. is listed as the recalling firm, operating out of Plymouth, MN. Federal records list the affected scope as 1256 boxes ( 2 wires/box).
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1256 boxes ( 2 wires/box)
Related Recalls
6
3 from same agency
Product description
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.
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1747-2014 |
| Date reported | June 18, 2014 |
| Date initiated | March 31, 2014 |
| Recalling firm | Neo Metrics, INC. |
| Firm location | Plymouth, MN |
| Affected scope | 1256 boxes ( 2 wires/box) |
| Distribution | Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1747-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Neo Metrics, INC.. Units affected: 1256 boxes ( 2 wires/box).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 18, 2014. Severity: Moderate. Recall number: Z-1747-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1747-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 18, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.