FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
- Recall number
- Z-1748-2013
- Recalling firm
- Boston Scientific Corporation
- Product
- Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (BSC), Sunnyvale, CA The Alair Bronchial Thermoplasty System (including the Alair Bronchial Thermoplasty Catheter) is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not well controlled with inhaled corticosteroids and long acting beta agonists.
- Status
- Terminated
- Initiated
- 2013-05-28
- Posted
- 2013-07-17
- Terminated
- 2013-08-28
- Reason
- Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inner tray, 2012-04, is incorrect. The correct expiration date is 2014-04 as indicated on the outer box label.
- Root cause
- Error in labeling
- Action
- The firm, Boston Scientific, sent a letter dated May 28, 2013, via express mail to all its direct consignees. The letter described the product, problem and actions to be taken. The customers were informed that you can continue to use the device until the expiration date on the outer box lablel, 2014-04; No product is being recalled and the you are not required to return product to Boston Scientific. The customers were instructed to read the enclosed information carefully and post the information in a conspicuous location near the affected product and/or take such other steps, consistent with your internal policies and procedures, to ensure that the information is easily accessible to all users of this device; and to complete and return the Customer Acknowledgment Form even if you no longer have any units from the affected lot/batch via email: MapleGroveFieldAc@bsci.com or Fax to: Field Action Center - 1866-213-1806. If you have any questions, call 763-494-1133 or email: MapleGroveFieldAc@bsci.com .
- Quantity
- 35 units
- Distribution
- Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
- Lot, serial or model codes
- Lot/batch Number: CM040212; Exp. Date: April 2014
- 510(k) numbers
- not on file
- PMA numbers
- ["P080032"]
- Product code
- OOY
- Firm FEI
- 3005099803
- Firm city
- Marlborough
- Firm state
- MA
- 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