FDA-Device2016-05-04Class II
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
Boston Scientific Corporation
Hazard
Mislabeled: 10mm diameter x 30mm length Ultraflex Tracheobronchial stents were labeled as 12mm diameter x 30mm
Sold states
Nationwide Distribution to AL, CA, MA, and TX.
Affected count
4 units
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1567-2016Don't want to check this manually?
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