INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
FDA device recall Z-1724-2025 · posted 2025-05-06 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Reason for recall
- Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KTI
- Quantity affected
- 6 units
- Distribution
- US Nationwide distribution in the states of TX, MT, AL & OK.
- Date initiated
- 2025-04-04
- Date posted
- 2025-05-06
- Location
- Princeton, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSPIRA AIR BALLOON DILATION SYSTEM (K110218) | Acclarent, Inc. | 2011-03-31 |