Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling, add warnings, and clarify instructional steps.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a Class II labeling correction to add warnings and clarify instructions, which aligns with the rubric for minor labeling errors or voluntary precautionary recalls.
Plain-English summary
Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 14 x 40 mm, with a 12 cc syringe volume. The recall involves 3,324 units of the device, which is used for the dilation of the airway tree. The product code is BC1440A, and the recall includes all lots manufactured after March 1, 2011.
The recall is a labeling correction intended to include additional language and warnings, as well as to clarify some instructional steps. The agency has classified this as a Class II recall.
The affected products were distributed nationwide in the United States, as well as in Belgium, Canada, and Saudi Arabia. Users of the device should contact Acclarent, Inc. for further instructions regarding the labeling update.
The recalled product
- Product
- Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Airway Dilation
- Hazard
- Affected units
- 3,324
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Product code: BC1440A
- All lots manufactured after March 1
- 2011
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Acclarent, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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