Recall Z-1747-2014 ยท OCY Endoscopic Guidewire, Gastroenterology-Urology
NEO METRICS, INC.
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 placeme
| Date | Jun 10, 2014 (initiated Mar 31, 2014) |
| Status | Terminated |
| Reason | 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 | 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 ca |
| Quantity | 1256 boxes ( 2 wires/box) |
| Distribution | Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133076 | NOVAGOLD HIGH PERFORMANCE GUIDEWIRE Neometrics, Inc., Feb 20, 2014 |