Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
FDA device recall Z-0563-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Incorrect label states stent covered with 'Permalume Covering', product is uncovered
- Action taken
- Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 12 units
- Distribution
- CA, GA, , MD, NY, OR, ND, PA Netherlands
- Date initiated
- 2004-01-28
- Date posted
- 2004-07-20
- Date terminated
- 2006-06-28
- Location
- Natick, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM (K030107) | Boston Scientific Corp | 2003-03-21 |
| WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE (K012752) | Boston Scientific Corp | 2001-11-15 |