Cuff, Tracheal Tube, Inflatable
FDA adverse event reports and recall history for cuff, tracheal tube, inflatable (product code BSK), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 421
- Deaths
- 9
- Injuries
- 40
- Malfunctions
- 371
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-07-01Open, ClassifiedProcess design
IntelliCuff, Portable automatic cuff pressure controller REF: 951001
Due to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to maintain the cuff pressure set by the user.
- 2023-09-29Open, ClassifiedComponent design/selection
Puritan Bennett Cuff Pressure Manager, REF: 180-03
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.
- 2013-10-01TerminatedProcess change control
H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment.
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
- Open, ClassifiedComponent design/selection
Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanical ventilation. Used in the ventilation of adults, pediatrics, and neonates.
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Monitor cuff, tracheal tube, inflatable automatically
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