Z-1095-2012

Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive...

Name: Z-1095-2012 Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive...
Creator: Acclarent, Inc.
Published: 2012-01-30
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2012-01-30 / Terminated / root cause: design

FDA source

Acclarent, Inc. began a recall of Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway... on 2012-01-30. The reason FDA records is "Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1095-2012
Status: Terminated
Initiated: 2012-01-30
Posted: 2012-03-01
Terminated: 2013-08-29
Recalling firm: Acclarent Inc
Product: Inspira AIR Balloon Dilation System, size 18 x 40; Manufactured by Acclarent, Inc. 1525-G O'Brien Drive, Menlo Park, CA 94025 Product Usage: Dilation of airway tree.
Product code: KTI Bronchoscope Accessory
Reason for recall: Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
Root cause tag: design
FDA root cause: Component design/selection
Action: Acclarent sent an "Urgent Voluntary Product Recall" letter dated January 31, 2012 by US mail, return receipt requested to all affected customers. Additionally, customers known to have scheduled procedures using the affected product were notified by phone to advise them of the recall. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use and return any remaining in stock per the instructions provided. The letter provides additional information and photographs illustrating how to identify the recalled product. Customers were advised to complete the enclosed Business Reply Card regardless of whether they have or do not have product subject to this recall in their possession and mail to Stericycle. Customers were instructed to distribute this information to all staff within their department who uses the affected product. For further questions call 1-866-781-1173 or contact your Acclarent Sales Representative.
Quantity in commerce: 633 units
Distribution: Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia
Product codes and lots: Product code BC1840A, Size 18 x 40: Lot 110307E, Exp 3/2013; Lot 110429E, Exp 4/2013; Lot 110502B, Exp 5/2013; Lot 110506B, Exp 5/2013; Lot 110606B, Exp 6/2013; Lot 110614B, Exp 6/2013.

Product code KTI

K110218Class IIInspira Air Balloon Dilation SystemAcclarent, Inc. / cleared 2011-03-31

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)