Acclarent, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1863-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

Product Classification:

Class II

Date Initiated: January 11, 2013

Date Posted: August 7, 2013

Recall Number: Z-1863-2013

Event ID: 64625

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.

Status: Terminated

Product Quantity: 2703

Code Information:

Product code: BC1040A; All lots manufactured after March 1, 2011

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

Voluntary or Mandated:

Voluntary: Firm initiated