INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
FDA Recall Z-1724-2025 · Posted 2025-05-06
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Recalling FirmIntegra LifeSciences Corp. (NeuroSciences)
Recall StatusOpen, Classified
Product CodeKTI
Date Initiated2025-04-04
Product Quantity6 units
Reason for Recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Firm Action
A "1st NOTIFICATION - URGENT: VOLUNTARY MEDICAL DEVICE RECALL" dated 4/4/25 was mailed to consignees. The notice instructs consignees to inspect their inventory for affected devices and immediately quarantine any identified units. Consignees are asked to forward the notice to users in their facility of the device being recalled and to maintain a copy of the notice for their records. The provided Acknowledgement Form is to be completed and returned to Integra via FAX at 1-609-750-4220 or by email to [email protected]. RMA numbers will be provided to consignees upon receipt of the Acknowledgement Form by Integra. Consignees with any questions can call Acclarent Customer Service Monday through Friday from 6:30 AM PST to 4:30 PM PST at 1-877-755-2789 or by email at [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of TX, MT, AL & OK.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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