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U.S. Department of Health and Human Services

Class 2 Device Recall NovaGold

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 Class 2 Recall
NovaGold
see related information
Date Posted June 10, 2014
Recall Status1 Open
Recall Number Z-1747-2014
Recall Event ID 68279
Premarket Notification
510(K) Number
K133076 
Product Classification Endoscopic Guidewire, Gastroenterology-Urology - Product Code OCY
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.
Code Information MO26343, MO26345, MO26724, MO27402, MO26342, MO26344, MO26731, MO27401, MO27660, MO27901, MO27659, MO27820, MO27899
Recalling Firm/
Manufacturer
NEO METRICS, INC.
2605 Fernbrook Ln N Ste J
Plymouth, Minnesota 55447-4756
Manufacturer 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.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OCY and Original Applicant = NEOMETRICS, INC.
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