Pathway Balloon Expandable Ureteral Access Sheath- 11/14/46, Ureteral dilator, Catalog Number: 255102; Product Number: M
FDA device recall Z-0907-2008 · posted 2008-04-30 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Sheath Removal Difficulty: Users experience difficulty in removing the sheath.
- Action taken
- Consignees were sent an Urgent Medical Device Recall letter on November 29, 2007. The letter instructed users to check their inventory, remove any affected product and place them in quarantine. It also included instructions for returning the product. Users were asked to return a Reply Verification Tracking Form. Follow-up communication will be made to users who do not return the tracking form.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- EZN
- Quantity affected
- 118
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-11-30
- Date posted
- 2008-04-30
- Date terminated
- 2008-10-22
- Location
- Quincy, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS (K061009) | Onset Medical Corporation | 2006-05-02 |