Recall Z-0908-2008 ยท EZN Dilator, Catheter, Ureteral
Boston Scientific Corporation
Pathway Balloon Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030, Onset Medical, Boston Scientific Corp., Natick, MA 01760
| Date | Apr 30, 2008 (initiated Nov 30, 2007) |
| Status | Terminated |
| Reason | Sheath Removal Difficulty: Users experience difficulty in removing the sheath. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 104 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS Onset Medical Corporation, May 2, 2006 |