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

FDA device recall Z-1095-2012 · posted 2012-03-01 · Terminated

Recall details

Recalling firm

Acclarent, Inc.

Reason for recall

Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

KTI

Quantity affected

633 units

Distribution

Nationwide Distribution (USA) only sixe 18 x 40 Worldwide distribution other sizes.Distirbution to France, Canada, Saudi Arabia

Date initiated

2012-01-30

Date posted

2012-03-01

Date terminated

2013-08-29

Location

Menlo Park, CA

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