Z-1748-2013Class II

Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog...

Name: Z-1748-2013 Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog...
Creator: Boston Scientific Corporation
Published: 2013-05-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-05-28 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and... on 2013-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1748-2013
Classification: Class II
Status: Terminated
Initiated: 2013-05-28
Posted: 2013-07-17
Terminated: 2013-08-28
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.
Product code: OOY Bronchial Thermoplasty System
Reason for recall: 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 tag: labeling and UDI
FDA 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: [email protected] or Fax to: Field Action Center - 1866-213-1806. If you have any questions, call 763-494-1133 or email: [email protected] .
Quantity in commerce: 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.
Product codes and lots: Lot/batch Number: CM040212; Exp. Date: April 2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1748-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1748-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-24	2013-07-17

Product code OOY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)