IntelliCuff 951001Recalls & reported problems

Summary

The FDA's MAUDE database contains 202 adverse event reports that list this exact device (DI 07630002800839), received between Dec 17, 2021 and Feb 13, 2026 — classified as 2 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (123 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K150893); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 22, 2026Open, Classified

   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 · Root cause: Process design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 202 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Complete Loss of Power

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: INTELLICUFF SWITCHED OFF WHILE IT WAS USING ON PATIENT. ADDITIONAL DEVICE NEEDED. NO HEALTH CONSEQUENCES OR IMPACT, WERE REPORTED. THE INVESTIGATION TO VERIFY THE ALLEGATION IS STILL IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330585 ↗
• MalfunctionNov 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23642008 ↗
• MalfunctionNov 25, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641587 ↗
• MalfunctionNov 25, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23641459 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION:THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630424 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING USE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION. THE MENTION OF "DURING USE" IS UNCLEAR AND WAS QUESTIONED BUT NO FEEDBACK WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23630143 ↗
• MalfunctionNov 24, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING USE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION. THE MENTION OF "DURING USE" IS UNCLEAR AND WAS QUESTIONED BUT NO FEEDBACK WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629949 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING USE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION. THE MENTION OF "DURING USE" IS UNCLEAR AND WAS QUESTIONED BUT NO FEEDBACK WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629674 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629400 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10 DURING INSPECTION OF THE DEVICE. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629213 ↗
• MalfunctionNov 24, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE DEVICE ALARMED WITH TF10. NO PATIENT WAS INVOLVED AS PER PROVIDED INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23628897 ↗
• MalfunctionJun 12, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION THE USER REPORTED THAT THE DEVICE ALARMED WITH ¿CUFF LEAK¿ AND "CHECK INTELLICUFF" DURING THE VENTILATION OF A PATIENT . THIS INTELLICUFF WAS INCORPORATED INTO HAMILTON-C6. THE USE OF INTELLICUFF INCORPORATED IN THIS C6 WAS DISCONTINUED, AND TREATMENT WAS CONTINUED USING A STAND-ALONE TYPE OF INTELLICUFF. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191920 ↗
• MalfunctionJun 12, 2025Mechanical Jam; Mechanical Jam

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION THE DEVICE ALARMED WITH TF: PRESSURE DOES NOT RISE. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191762 ↗
• MalfunctionJun 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION SUDDENLY, THE SCREEN BEGAN TO FLASH AND THE POWER WOULD NOT TURN OFF. THE EVENT OCCURRED WHILE PERFORMING POST-USE OPERATIONAL CHECKS. THE LOG SHOWED THAT TF10 WAS RECORDED THREE TIMES. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121550 ↗
• MalfunctionJun 2, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING EVENT DESCRIPTION: THE SCREEN SUDDENLY LIT UP AND THE ALARM SOUNDED CONTINUOUSLY. THIS OCCURRED WHILE THE DEVICE WAS BEING USED ON A PATIENT. HOSPITAL STAFF REPLACED THE DEVICE WITH ANOTHER ONE AND CONTINUED TREATMENT. THE LOG SHOWS THAT TF10 HAS OCCURRED. NO HARM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121520 ↗
• MalfunctionJun 2, 2025Gas/Air Leak; Gas/Air Leak

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: DURING USE, A ¿CUFF LEAK¿ ALARM OCCURRED AND CONTINUED. THE DEVICE WAS EXCHANGED WITH ANOTHER INTELLICUFF DEVICE. NO HAM TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22121505 ↗
• MalfunctionMay 19, 2025Gas/Air Leak; Gas/Air Leak

  DURING USE, A ¿CUFF LEAK¿ ALARM OCCURRED AND CONTINUED. AT A CUFF PRESSURE SETPOINT OF 25HPA, THE CUFF PRESSURE DIDN¿T RAISE ABOVE 21HPA. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM. THE INTELLICUFF DEVICE HAS BEEN EXCHANGED. THE PROVIDED INFORMATION REASONABLY SUGGESTS THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. THIS MAKES THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22044090 ↗
• MalfunctionMay 6, 2025Gas/Air Leak; Gas/Air Leak

  ¿ HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE DESIRED PRESSURE CANNOT BE REACHED". THERE IS NO PATIENT INVOLVEMENT REPORTED. ¿ THE INTELLICUFF DEVICE WAS REPLACED. INFORMATION REASONABLY SUGGESTS THAT THE INTELLICUFF DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21967042 ↗
• MalfunctionMay 6, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  HAMILTON MEDICAL RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "DURING ROUTINE INSPECTION, IT WAS NOTICED THAT THE CONNECTOR PART OF THE INTELLICUFF DEVICE WAS CRACKED". THERE IS NO PATIENT INVOLVEMENT REPORTED. IF THE SAME ISSUE WERE TO RECUR DURING VENTILATION, AN IMPACT ON THE PATIENT CAN NOT BE EXCLUDED. THEREFORE, THE CASE IS ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966305 ↗
• MalfunctionMay 5, 2025Decrease in Pressure; Insufficient Device Problem Information; Decrease in Pressure; Insufficient Device Problem Information

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "THE INTELLICUFF DEVICE WAS CONNECTED TO A HAMILTON-C6 VENTILATOR DEVICE. DURING PATIENT VENTILATION THE MESSAGES ¿CHECK INTELLICUFF STATE¿ AND ¿CHECK INTELLICUFF¿ FREQUENTLY APPEARED ON THE DISPLAY OF THE HAMILTON-C6 VENTILATOR DEVICE¿. MEDICAL INTERVENTION PERFORMED BY REPLACING THE INTELLICUFF DEVICE AND THE VENTILATOR DEVICE. THE ISSUE DID NOT RESULT IN ANY PATIENT HARM BUT IF IT WERE TO RECUR AN IMPACT ON PATIENT COULD NOT BE EXCLUDED. THEREFORE, THIS EVENT IS ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961002 ↗
• MalfunctionMay 5, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: "WHILE THE PATIENT WAS USING THE DEVICE, ALL THE DISPLAY LIGHTS CAME ON AND THE ALARM SOUNDED CONTINUOUSLY. AS A RESULT, USE OF THIS INTELLICUFF DEVICE WAS SUSPENDED. THE LOG SHOWS NUMEROUS TF10 ENTRIES¿. AN IMPACT ON THE PATIENT IF IT WERE TO RECUR CANNOT BE EXCLUDED. THEREFORE, THIS EVENT IS ASSESSED AS REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21960378 ↗
• MalfunctionApr 29, 2025Insufficient Cooling; Off-Label Use; Insufficient Cooling; Off-Label Use

  THE HAMILTON-MR1 VENTILATOR DEVICE ALERTED FOR ¿FAN FAILURE¿. THERE IS NO PATIENT INVOLVEMENT. THE DEVICE LOG FILES ARE PROVIDED. THE DEVICE LOGFILES SHOWN SEVERAL TECHNICAL FAULTS. EVEN THOUGH THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THE REPORTED EVENT, IT CANNOT BE EXCLUDED THAT THE POTENTIAL MALFUNCTION (IF CONFIRMED) WOULD NOT CONTRIBUTE TO DEATH OR SERIOUS INJURY IF THE MALFUNCTION (AGAIN IF CONFIRMED AS A USER ERROR IS NOT EXCLUDED) WERE TO RECUR. POTENTIALLY IT IS NOT CLEAR IF THE USER WAS PLACING PRIOR TO THE REPORTED EVENT THE VENTILATOR TO CLOSE TO THE MRI DEVICE WHICH WOULD CONDUCT TO THE REPORTED ISSUE. INVESTIGATION IS THEREFORE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924743 ↗
• MalfunctionApr 29, 2025Gas/Air Leak; Gas/Air Leak

  ¿ HAMILTON MEDICAL AG RECEIVED THE FOLLOWING INCIDENT DESCRIPTION: DURING USE, A ¿CUFF LEAK¿ ALARM OCCURRED AND CONTINUED. AS A RESULT, THE HOSPITAL REQUESTED REPAIR OF THE INTELLICUFF DEVICE. AFTER CHECKING THE OPERATION, IT WAS FOUND THAT IT ONLY PRESSURIZED TO ABOUT 18 HPA AT A SETTING OF 25 HPA. ¿ THERE WAS NO PATIENT HARM REPORTED. MEDICAL INTERVENTION HAS TAKEN PLACE, THE INTELLICUFF DEVICE GOT EXCHANGED. ¿ THE PROVIDED INFORMATION REASONABLY SUGGESTS THAT THE DEVICE HAS MALFUNCTIONED AND THAT THE DEVICE OR A SIMILAR DEVICE WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21923967 ↗
• MalfunctionMar 17, 2025Gas/Air Leak; Gas/Air Leak

  THE INTELLICUFF DEVICE CONTINUOUSLY ALERTED FOR A LEAK. THERE IS NO PATIENT INVOLVEMENT REPORTED. THE DEFECT INTELLICUFF DEVICE GOT REPLACED. A LOW CUFF PRESSURE COULD LEAD TO INADEQUATE VENTILATION WHAT MAKES THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21620314 ↗
• MalfunctionMar 17, 2025Break; Crack; Break; Crack

  THIS EVENT WAS REPORTED TO HAMILTON MEDICAL AG AS THE CUFF PRESSURE TUBE CONNECTOR, WHICH IS LOCATED AT THE BOTTOM OF THE INTELLICUFF HANDHELD HOUSING, HAS BEEN BROKEN OFF. THIS CAUSES A LEAK IN THE CIRCUIT, PREVENTING THE PRESSURE FROM RISING. THERE IS NO PATIENT INVOLVEMENT REPORTED. A LOW CUFF PRESSURE COULD LEAD TO INADEQUATE VENTILATION WHAT MAKES THIS EVENT REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619939 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150893. One submission often covers many models, so check the product and lot details in each record.

• Z-0335-2018 · Jun 20, 2017 · Open, Classified
  Intellicuff Standalone (PN 951001) Used to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube or tracheostomy tube during mechanica