IntelliCart™ 00-5140-101-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00889024465992), received between Jul 3, 2019 and Jul 7, 2025 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Smoking” (8 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2025Fire; Fire

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT CAUGHT ON FIRE WHEN EMPTYING. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22416737 ↗
• MalfunctionMay 7, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT WAS OVERHEATING AND SMOKE CAME OUT OF THE IT. NO HARM OR DELAY WAS REPORTED AS THERE WAS NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977140 ↗
• MalfunctionMay 15, 2024Device Emits Odor; Overheating of Device; Smoking; Device Emits Odor; Overheating of Device; Smoking

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19324832 ↗
• MalfunctionMay 2, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT SHOWS THAT IT IS FULL BUT IT IS NOT FULL IN BOTH CYLINDERS. NO PATIENT INVOLVEMENT, IMPACT, OR HARM. DUE DILIGENCE INFORMATION COMPLETE SINCE QUOTE WAS REJECTED AFTER NO RESPONSE FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231984 ↗
• MalfunctionMay 2, 2024Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED THAT THE UNIT DOES NOT SHOW THE FLUID VOLUME. THERE IS FLUID IN THE UNIT BUT DOESN'T SHOW HOW MUCH. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE FLUID VOLUME WAS INCORRECT IN BOTH CYLINDERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228966 ↗
• MalfunctionDec 21, 2023Device Emits Odor; Smoking; Device Emits Odor; Smoking

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370990 ↗
• MalfunctionJun 22, 2023Suction Problem; Suction Problem

  IT WAS REPORTED THAT THERE WAS A SUCTION ISSUE. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. UPON INVESTIGATION, THERE WAS A CHAR IN THE FUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17184152 ↗
• MalfunctionMar 29, 2023Circuit Failure; Melted; Circuit Failure; Melted

  IT WAS REPORTED THAT THE FUSE BOX IS BURNT. DUE DILIGENCE PERFORMED CONFIRMED THAT THE FUSES WERE BLOWN. THE POWER INLET MODULE HAD SIGNS OF MELTING DUE TO EXCESSIVE HEAT. THIS EVENT OCCURRED OUTSIDE THE SURGICAL ENVIRONMENT. THERE WAS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT INVESTIGATION THE UNIT WAS CONFIRMED TO HAVE A BURNT AND MELTED POWER INLET MODULE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16639400 ↗
• MalfunctionFeb 6, 2023Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT THE UNIT WAS SMOKING, AND IT WAS CHARRED ON THE BACK BY THE PLUG IN. THE ISSUE DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED PATIENT IMPACT. DUE DILIGENCE IS COMPLETE AND THERE IS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16307593 ↗
• MalfunctionFeb 3, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THIS UNIT WILL NOT CONNECT. THE EVENT DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. UPON DEVICE EVALUATION IT WAS FOUND THE BOARD WAS BURNED. NO ADVERSE EVENT WAS REPORTED. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16293191 ↗
• MalfunctionJan 12, 2023Fluid/Blood Leak; Connection Problem; Fluid/Blood Leak; Connection Problem

  IT WAS REPORTED THAT THE UNIT IS LEAKING AND NOT CONNECTING TO CART. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO HARM OR DELAY REPORTED. UPON INVESTIGATION, THERE WERE BLACK PIT MARKS NOTED ON THE NOSE BOARD. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146536 ↗
• MalfunctionJul 28, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE FLUID LEVELS IN BOTH CYLINDERS WERE INCORRECT. NO HARM OR DELAY WERE REPORTED. NO OTHER ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15122000 ↗
• MalfunctionJul 22, 2022Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT UNIT WILL NOT TURN ON WHEN PLUGGED INTO WALL AND THE PLUG SHOWS SIGNS OF BEING BURNT. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT HARM REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084008 ↗
• MalfunctionJul 15, 2022Electrical /Electronic Property Problem; Infusion or Flow Problem; Electrical /Electronic Property Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT THE VALVE PACK WAS NOT ROTATING AND THE POWER INLET MODULE NEEDED TO BE CHANGED. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION FOUND EVIDENCE THAT THE FUSE BURNT THE POWER INLET MODULE AND THE POWER INLET MODULE HAD DISCOLORATION. THERE WAS NO SMOKE PRESENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026159 ↗
• MalfunctionJun 29, 2022Protective Measures Problem; No Apparent Adverse Event; Protective Measures Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS UNIT BEGAN TO BEEP AND GIVE A PM NOTICE ON START UP BUT THEY WERE NOT ABLE TO USE THE UNIT IN A CASE. THEY STATED THAT AFTER CLEARING THE PM TIMER THE UNIT STILL BEEPED. THE EVENT DID NOT OCCUR DURING SURGERY, AND THERE WAS NO PATIENT INVOLVEMENT. UPON DEVICE INSPECTION, THE INSIDE OF THE POWER INLET MODULE WAS BURNT AND DAMAGED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14853224 ↗
• MalfunctionJun 10, 2022Overheating of Device; No Apparent Adverse Event; Overheating of Device; No Apparent Adverse Event

  IT WAS REPORTED THIS CART HAD AN OVERHEAT ERROR. THE EVENT TIMING AFTER SURGERY. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS DISCOVERED THAT THE POWER INLET MODULE WAS BURNT AND WOULD NOT POWER ON. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14652909 ↗
• MalfunctionJun 2, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THAT POWER CABLE WIRES WERE EXPOSED. THE EVENT OCCURRED OUTSIDE OF SURGERY, AND THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14572720 ↗
• MalfunctionMay 31, 2022Smoking; Smoking

  IT WAS REPORTED THAT THE UNIT STARTED TO SMOKE MID CASE. THE EVENT TIMING IS DURING SURGERY. THERE IS NO HARM TO THE PATIENT OR OPERATOR. THERE WAS A 5-10 MINUTE DELAY. THERE IS NO ADDITIONAL INFORMATION AVAILABLE FROM THE CUSTOMER. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14546650 ↗
• MalfunctionApr 6, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE CART WOULD NOT POWER ON FROM WALL POWER. THE EVENT TIMING WAS DURING CLEANING. THERE IS NO HARM OR DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14024943 ↗
• MalfunctionApr 5, 2022Smoking; Smoking

  IT WAS REPORTED THAT THIS CART HAD SMOKE COMING FROM IT PRIOR TO SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014211 ↗
• MalfunctionMar 24, 2022Melted; Failure to Power Up; Melted; Failure to Power Up

  IT WAS REPORTED THAT AFTER SURGERY THE UNIT WOULD NOT POWER ON AND THE POWER INLET MODULE AND POWER CORD WERE MELTED. THERE WERE SIGNS OF CHARRING. NO HARM REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13891337 ↗
• MalfunctionMar 18, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE UNIT THAT WOULD NOT POWER ON FROM WALL POWER. THE EVENT TIMING WAS PRIOR TO SURGERY AND THERE WAS NO PATIENT INVOLVEMENT REPORTED. EVALUATION OF THE DEVICE LATER FOUND THAT THE POWER INLET MODULE WAS MELTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13804290 ↗
• MalfunctionSep 8, 2021Overheating of Device; Failure to Power Up; Overheating of Device; Failure to Power Up

  IT WAS REPORTED THAT THE CART WAS NOT POWERING ON VIA THE WALL. THE EVENT TIMING WAS DURING CLEANING. THERE WAS NO HARM TO THE PATIENT. INVESTIGATION FOUND THERE WAS BURNING/CHARRING OF A RESISTOR IN THE FUSE BOX; CAUSED BY A LOOSE/POOR FUSE CONNECTION GENERATING HEAT. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439261 ↗
• MalfunctionAug 23, 2021Overheating of Device; Electrical Power Problem; Overheating of Device; Electrical Power Problem

  IT WAS REPORTED THIS UNIT WILL NOT POWER ON VIA WALL POWER. FOUND IT WILL POWER ON VIA THE EVACUATION UNIT. THE EVENT TIMING WAS DURING CLEANING. INVESTIGATION FOUND THE POWER INLET MODULE WAS BURNT AND THE CORD HAD HEAT DAMAGE. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12352998 ↗
• MalfunctionMar 10, 2021Melted; Melted

  IT WAS REPORTED THAT (B)(6) (CUSTOMER) CALLED IN TO OPEN A WORK ORDER AS IT WAS REPORTED TO HER THAT THIS UNIT WOULD NOT POWER ON DURING CLEANING. INVESTIGATION SHOWED THE POWER INLET MODULE FUSE HOUSING WAS MELTED AND THE FUSE WAS BAD. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11454692 ↗