Device product
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 diameters and lengths
Z-1567-2016
Product summary
- Event
- Event 73660
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1567-2016
Official wording
Reason: Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Code information: Lot Number: 18876596 Exp Date: February 1, 201 8
Distribution pattern: Nationwide Distribution to AL, CA, MA, and TX.
Derived failure modes
-
Labeling or packaging
Mislabeled