Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M005
FDA device recall Z-1747-2014 · posted 2014-06-10 · Terminated
Recall details
- Recalling firm
- NEO METRICS, INC.
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OCY
- Quantity affected
- 1256 boxes ( 2 wires/box)
- Distribution
- Worldwide Distribution - US and the countries of Austria, Belgium, Germany, Spain, France, Great Britain, Italy, Netherlands and Sweden.
- Date initiated
- 2014-03-31
- Date posted
- 2014-06-10
- Date terminated
- 2015-01-16
- Location
- Plymouth, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (K133076) | Neometrics, Inc. | 2014-02-20 |