Alveolus, Inc. Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
Brand
Alveolus, Inc.
Lot Codes / Batch Numbers
Size 12x40, Part #90129-20, Lot #AC0406, Size 14x40, Part #90129-21, Lot #AC0409, Size 16x40, Part #90129-22, Lot #AA0411, Size 16x60, Part #90129-23, Lot #A0413, Size 12x20, Part #90129-24, Lot #AA0404, Size 14x40, Part #90129-25, Lot 3AA0409, Size 14x40, Part #90129-26, Lot #AC0409, Size 16x60, Part #90129-27, Lot #AA0413
Products Sold
Size 12x40, Part #90129-20, Lot #AC0406; Size 14x40, Part #90129-21, Lot #AC0409; Size 16x40, Part #90129-22, Lot #AA0411; Size 16x60, Part #90129-23, Lot #A0413; Size 12x20, Part #90129-24, Lot #AA0404; Size 14x40, Part #90129-25, Lot 3AA0409; Size 14x40, Part #90129-26, Lot #AC0409; Size 16x60, Part #90129-27, Lot #AA0413
Alveolus, Inc. is recalling Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 Nor due to The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The tracheal stent may collapse resulting in blockage of the air passage because the stents were not properly coated with the polyurethane material to the very end of the stent.
Recommended Action
Per FDA guidance
Consignees were notified by telephone on 4/22/2004.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, SC, TX
Page updated: Jan 10, 2026