Recall Z-1724-2025 ยท KTI Bronchoscope Accessory
Integra LifeSciences Corp. (NeuroSciences)
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
| Date | May 6, 2025 (initiated Apr 4, 2025) |
| Status | Open, Classified |
| 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 Acknowledgem |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the states of TX, MT, AL & OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110218 | INSPIRA AIR BALLOON DILATION SYSTEM Acclarent, Inc., Mar 31, 2011 |