Alair Bronchial Thermoplasty Catheter, Bronchial… recallZ-1748-2013 · Boston Scientific Corporation · initiated May 28, 2013
Class II Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Error in labeling
What the company is doing
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: [email protected] or Fax to: Field Action Center - 1866-213-1806. If you have any questions, call 763-494-1133 or email: [email protected] .
Recall details
- Recall number
- Z-1748-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 28, 2013
- Posted by the FDA
- Jul 17, 2013
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 35 units
- Product code
- OOY
- FDA submissions
- P080032
- Distribution
- Worldwide distribution: US (nationwide) including states of: CA, FL, IA, ID, MI, OK, TA and WA; and countries of: Canada and Thailand.
Product description
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.
Code information (models, lots, serial numbers)
Lot/batch Number: CM040212; Exp. Date: April 2014
Other devices under the same FDA submission
2 devices cleared under P080032 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ALAIR™ M005ATS25010Boston Scientific Corporation · Bronchial thermoplasty system89 reports
- Alair Bronchial Thermoplasty RF Controller ATS 200Boston Scientific Corporation · Bronchial thermoplasty system2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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