Cuff, Tracheal Tube, Inflatable
Anesthesiology · 21 CFR 868.5750
Recent MDR events
421 adverse event reports on file
- INTELLICUFFJun 26, 2026MalfunctionHamilton Medical Ag3001421318-2026-00391
- PURITAN BENNETTApr 17, 2026MalfunctionCovidien2936999-2026-00136
- PURITAN BENNETTApr 17, 2026MalfunctionCovidien2936999-2026-00137
- INTELLICUFFApr 9, 2026MalfunctionHamilton Medical Ag3001421318-2026-00204
- AG CUFFILL (CMH2O)Mar 30, 2026MalfunctionHospitech Respiration Ltd24710306
- PURITAN BENNETTMar 23, 2026MalfunctionCovidien2936999-2026-00090
- PURITAN BENNETTMar 17, 2026MalfunctionCovidien2936999-2026-00084
- INTELLICUFF STANDALONEFeb 13, 2026MalfunctionHamilton Medical Ag3001421318-2026-00065
- PURITAN BENNETTFeb 4, 2026InjuryMedtronic, Inc.2182208-2026-01654
- PURITAN BENNETTJan 29, 2026MalfunctionMedtronic, Inc.2182208-2026-01533
Event type breakdown
Recalls
4 recall events for this product code
- Hamilton Medical AGOpen, ClassifiedJul 1, 2026
IntelliCuff, Portable automatic cuff pressure controller
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.
Z-2625-2026 · View FDA record ↗ - CovidienOpen, ClassifiedSep 29, 2023
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.
Z-2651-2023 · View FDA record ↗ - H & H AssociatesTerminatedOct 1, 2013
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 A
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
Z-0006-2014 · View FDA record ↗ - Hamilton Medical, Inc.Open, ClassifiedUnknown
Intellicuff Standalone (PN 951001)
Issue related to the performance of the motor in recalled product. During use, motor may cease to function.
Z-0335-2018 · View FDA record ↗
Registered firms
49 firms currently registered for this product code
Teleflex Medical De Mexico, S. De R.l. De C.v.
NUEVO LAREDO Tamaulipas, MX
The Laryngeal Mask Company (m) Sdn. Bhd.
Kulim Kedah, MY
Bd Medical Development
Crown Point, IN, US
Hamilton Medical Ag
Domat / Ems Graubunden, CH
Teleflex Medical Llc
Morrisville, NC, US
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Arch Medical Solutions - Seabrook
SEABROOK, NH, US
Medtronic (shanghai) Medical Technology Co., Ltd.
Min Hang District Shanghai, CN
Hospitech Respiration
Lod Central IL, IL
Quasar Engineering Ltd.
Kowloon, HK
Sunmed Group Holdings, Llc
Grand Rapids, MI, US
Remington Medical, Inc.
ALPHARETTA, GA, US
Globus Medical, Inc.
Memphis, TN, US
Tdg Technology Co., Ltd.
Jiaxing City Zhejiang, CN
Shanghai Longmann Tech Co., Ltd.
Shanghai, CN
Venner Medical (singapore) Pte Ltd
Singapore Central Singapore, SG
Isomedix Operations Inc.
SPARTANBURG, SC, US
Bryan Medical Inc.
Cincinnati, OH, US
Quadrant Technologies, Llc
Grayslake, IL, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Arch Medical Solutions - Memphis
Lexington, TN, US
Inoris Medical Sp. Z O.o.
Kowary Dolnoslaskie, PL
Tracoe Medical Gmbh
NIEDER-OLM Rhineland-Palatinate, DE
Hamilton Medical Ag
Domat/Ems Graubunden, CH
510(k) clearances
39 clearances for this product code
- IdmedAug 12, 2025
K243562 · CuffGuard
- Shanghai Longmann Tech Co., Ltd.Mar 7, 2025
K242642 · CuffTrek
- Aw Technologies ApsApr 14, 2023
K220854 · TrachCuff Cuff Controller
- Hospitech Respiration , Ltd.Dec 29, 2022
K221477 · AG100s
- Covidien, LLCJan 9, 2021
K202874 · Puritan Bennett Cuff Pressure Manager
- Biovo Technologies , Ltd.Aug 13, 2020
K192611 · Cuffix
- Kal-Med, LLCFeb 24, 2020
K191858 · Pylant Monitor
- Tianjin Medis Medical Device Co., Ltd.Jan 25, 2019
K182548 · Accucuff Cuff Pressure Indicator