The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1863-2013·Announced 2013-08-07

Acclarent Inspira AIR Balloon Dilation System Labeling Correction Recall

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 a labeling correction with no reported injuries or illnesses, fitting the criteria for minor labeling errors or voluntary precautionary recalls.

Plain-English summary

Acclarent, Inc. is recalling the Inspira AIR Balloon Dilation System, size 10 x 40 mm, with a 12 cc syringe volume. The recall involves 2,703 units distributed nationwide in the United States and in Belgium, Canada, and Saudi Arabia. The affected product code is BC1040A, and the recall includes all lots manufactured after March 1, 2011.

The recall is a labeling correction intended to include additional language and warnings and to clarify certain instructional steps for the dilation of the airway tree. The source text does not report any illnesses, injuries, or deaths associated with this recall.

Healthcare providers and facilities should stop using the affected devices and contact Acclarent, Inc. for instructions on how to return or dispose of the product. Consumers should not use the device and should contact their healthcare provider for guidance.

The recalled product

Product
Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Manufacturer
Acclarent, Inc.
Category
Medical Device — Airway Dilation
Hazard
Affected units
2,703

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: BC1040A
  • 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.

See all 7 products in this recall →

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