Acclarent Recalls Inspira AIR Balloon Dilation System for Labeling Corrections
Acclarent, Inc. is recalling Inspira AIR Balloon Dilation Systems to correct labeling 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 classified as FDA Class II and involves a labeling correction to clarify instructions and add warnings, which aligns with the rubric for moderate severity involving minor labeling errors or voluntary precautionary measures.
Plain-English summary
Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 16 x 40 mm, with a 12 cc syringe volume. The recall involves 2,175 units of the device, which is used for the dilation of the airway tree.
The recall is initiated to correct labeling for all sizes of the system. The corrections include adding additional language and warnings, as well as clarifying specific instructional steps. The affected product code is BC1640A, covering all lots manufactured after March 1, 2011.
The recalled devices 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 corrections.
The recalled product
- Product
- Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Manufacturer
- Acclarent, Inc.
- Category
- Medical Device — Airway Dilation
- Hazard
- Affected units
- 2,175
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: BC1640A
- 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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