INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Summary
The FDA issued a Class II for INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation cathete by Integra LifeSciences Corp. (NeuroSciences). Reason: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton..
Details
Source
Device Recall
External ID
Z-1724-2025
Action Date
2025-05-14
Status
Ongoing
Category
device
Product Description
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Lot/Code Info: Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Quantity Affected: 6 units
Reason for Recall
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-04
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 146 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Integra LifeSciences Corp. (NeuroSciences)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Integra LifeSciences Corp. (NeuroSciences) have FDA actions?
Integra LifeSciences Corp. (NeuroSciences) has 30 FDA actions in our database, including 30 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1724-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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