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Terminated

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

FDA Recall Z-1863-2013 · Posted 2013-08-01

Recalling FirmAcclarent, Inc.
Recall StatusTerminated
Product CodeKTI
Date Initiated2013-01-11
Date Terminated2013-10-25
Product Quantity2703

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.

Firm 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

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110218INSPIRA AIR BALLOON DILATION SYSTEMAcclarent, Inc. · 2011-03-31K090660AIRWAY BALLOON CATHETER INFLATION DEVICEAcclarent, Inc. · 2009-06-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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