Z-1747-2014Class II

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN...

Name: Z-1747-2014 Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN...
Creator: Neo Metrics, Inc.
Published: 2014-03-31
License: https://open.fda.gov/license/

Neo Metrics, Inc. / initiated 2014-03-31 / Terminated / root cause: manufacturing process

FDA source

NEO METRICS, INC. began a recall of Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc... on 2014-03-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1747-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-31
Posted: 2014-06-10
Terminated: 2015-01-16
Recalling firm: Neo Metrics, Inc.
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 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.
Product code: OCY Endoscopic Guidewire, Gastroenterology-Urology
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: NeoMetrics sent a letter dated March 31, 2014, to Boston Scientific. On March 24, 2014, Boston Scientific made NeoMetrics aware that Boston Scientific received 3 complaints from customers that the tip of the NovaGold guidewire detached and/or became uncoiled. Because the tips are breaking and/or uncoiling at a rate that was not anticipated, it has been decided that these units should be removed from the field. Therefore, NeoMetrics does not object to Boston Scientific executing this product removal in accordance with Section 4.4 of the distribution agreement. For further questions please call (763) 559-4440.
Quantity in commerce: 1256 boxes ( 2 wires/box)
Distribution: Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.
Product codes and lots: MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1747-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1747-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-10

Product code OCY

K133076Class IINovagold High Performance GuidewireNeometrics, Inc. / cleared 2014-02-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)