FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp. (NeuroSciences): INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Recall number
- Z-1724-2025
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
- Status
- Open, Classified
- Initiated
- 2025-04-04
- Posted
- 2025-05-06
- Terminated
- not on file
- Reason
- Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
- Root cause
- Under Investigation by 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 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
- 6 units
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
- Lot, serial or model codes
- Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
- 510(k) numbers
- ["K110218"]
- PMA numbers
- not on file
- Product code
- KTI
- Firm FEI
- 3003418325
- Firm city
- Princeton
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28