Z-1865-2013Class II

Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree

Name: Z-1865-2013 Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree
Creator: Acclarent, Inc.
Published: 2013-01-11
License: https://open.fda.gov/license/

Acclarent Inc / initiated 2013-01-11 / Terminated / root cause: design

FDA source

Acclarent, Inc. began a recall of Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree on 2013-01-11. FDA classified it as Class II and gives the reason as "Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps". 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-1865-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Posted: 2013-08-01
Terminated: 2013-10-25
Recalling firm: Acclarent Inc
Product: Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Product code: KTI Bronchoscope Accessory
Reason for recall: Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Root cause tag: design
FDA root cause: Device Design
Action: Urgent Medical Device Labeling correction letters will be sent to all consignees through a delivery system that can track delivery. After CDRH review and corrections, Acclarent began issuing customer notification on August 7, 2013
Quantity in commerce: 3324
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.
Product codes and lots: Product code: BC1440A; All lots manufactured after March 1, 2011

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1865-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1860-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1861-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1862-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1863-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1864-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1865-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01
Z-1866-2013	Class II	Terminated	Voluntary: Firm initiated	2013-08-07	2013-08-01

Product code KTI

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)