WALLSTENT Endoprostheses with UNISTEP Plus Delivery System.
FDA device recall Z-1340-04 · posted 2004-08-13 · Terminated
Recall details
- Recalling firm
- Boston Scientific Scimed
- Reason for recall
- Specific lots of the WALLSTENT Endoprosthesis with UNISTEP Plus Delivery System were packaged without one of the three required directions for use.
- Action taken
- Boston Scientific is notifying sales representatives and customers of recall along with instructions regarding the return of potentially affected product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JCT
- Quantity affected
- 82 units (H965402100) aa7 units (H965402100)
- Distribution
- Inside the US only.
- Date initiated
- 2004-07-09
- Date posted
- 2004-08-13
- Date terminated
- 2007-01-05
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM (K992510) | Boston Scientific Corp | 1999-11-18 |