Recall Z-1866-2013— Acclarent, Inc.

Name: FDA recall Z-1866-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-11

Class II · Terminated

Class II FDA medical device recall by Acclarent, Inc., initiated 2013-01-11, terminated 2013-10-25. It names 2 FDA 510(k) clearances: K110218, K090660. Product: Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.. Reason: 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..

Recalling firm: Acclarent, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-01-11
Terminated: 2013-10-25
Firm location: Menlo Park, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K110218 — INSPIRA AIR BALLOON DILATION SYSTEMAcclarent, Inc.·cleared 2011-03-31
K090660 — AIRWAY BALLOON CATHETER INFLATION DEVICEAcclarent, Inc.·cleared 2009-06-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.