Boston Scientific Ultraflex Covered Tracheobronchial Stent System - Distal Release (14/4/2.5) Material/UPN/Catalog Numbe
FDA device recall Z-2327-2010 · posted 2010-08-31 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Units have excessive fraying of the deployment suture thread, as a result, these devices may experience a suture break during deployment.
- Action taken
- Boston Scientific issued "Urgent Medical Device Recall - Immediate Action Required" letters dated July 15,2010 to consignees. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Foreign accounts received notification translated into the local language and with changes that are applicable to local regulations. Boston Scientific can be contacted at 1-508-683-4427.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JCT
- Quantity affected
- 10 units
- Distribution
- Worldwide Distribution: USA, and the countries of: Austria, Germany, Finland, France, UK, Ireland, Iran, Italy, the Netherlands, Portugual, Spain, and Sweden
- Date initiated
- 2010-07-15
- Date posted
- 2010-08-31
- Date terminated
- 2011-10-14
- Location
- Marlborough, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (K012883) | Boston Scientific Corp | 2001-10-12 |