FDA Medical Device Recalls (openFDA)
Alveolus, Inc.: Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
- Recall number
- Z-1487-04
- Recalling firm
- Alveolus, Inc.
- Product
- Alveolus Tracheobronchial Stent Technology System (TB-STS), Manufactured for: Alveolus Inc., 401 North Tryon Street, Charlotte, North Carolina USA 28202
- Status
- Terminated
- Initiated
- 2004-04-22
- Posted
- 2004-09-29
- Terminated
- 2005-01-12
- Reason
- 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.
- Root cause
- Other
- Action
- Consignees were notified by telephone on 4/22/2004.
- Quantity
- not on file
- Distribution
- FL, SC, TX
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FWN
- Firm FEI
- 3004039296
- Firm city
- Charlotte
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28