Recall Z-1567-2016 ยท JCT Prosthesis, Tracheal, Expandable
Boston Scientific Corporation
Boston Scientific Ultraflex Tracheobronchial Distal Release Stent System 12mm X 30mm Material Number: M00576550 The stent system is a permanently implanted expandable metal stent designed for palliation of tracheobronchial (TB) strictures. The system consists of a flexible delivery catheter preloaded with an expandable metal stent. The stent is offered in a variety of sizes of different diameter
| Date | Mar 18, 2016 |
| Status | Terminated |
| Reason | Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm |
| Root cause | Process control |
| Action | Boston Scientific issued notification letters dated March 17, 2016. The notification instructs the customer to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form. Customers with questions should call 866-868-4004. For questions regarding this recall call 508-382-9555. |
| Quantity | 4 units |
| Distribution | Nationwide Distribution to AL, CA, MA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141584 | ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM Boston Scientific Corporation, Oct 16, 2014 |