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U.S. Department of Health and Human Services

Class 2 Device Recall Inspira AIR Balloon Dilation System

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 Class 2 Device Recall Inspira AIR Balloon Dilation Systemsee related information
Date Initiated by FirmApril 04, 2025
Date PostedMay 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1724-2025
Recall Event ID 96672
510(K)NumberK110218 
Product Classification Bronchoscope accessory - Product Code KTI
ProductINSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Code Information Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information ContactMary O'Neill
1-640-867-9411
Manufacturer Reason
for Recall		Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
FDA Determined
Cause 2		Under Investigation by firm
ActionA "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 FCA@integralife.com. 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 ACCUSCS@integralife.com.
Quantity in Commerce6 units
DistributionUS Nationwide distribution in the states of TX, MT, AL & OK.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KTI
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