IntelliCart™ UE514010300Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024501645), received between Apr 14, 2021 and Nov 13, 2024 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2024Sparking; Sparking

  THERE WAS NO ADDITIONAL INFORMATION ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676166 ↗
• MalfunctionOct 23, 2024Fire; Sparking; Fire; Sparking

  IT WAS REPORTED THAT UNIT SPARKED AND CAUGHT FIRE DURING USE IN A PROCEDURE. NO PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517480 ↗
• MalfunctionSep 28, 2023Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD NO POWER, AND THE AC CORD HAS BURNT MARK. THE POWER INLET MODULE WAS NOT DAMAGED. THE UNIT HAD PHYSICAL EVIDENCE OF BURN. THE ACCOUNT DID NOT HAVE THE CART PLUGGED INTO A POWER STRIP OR EXTENSION CORD. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17837063 ↗
• MalfunctionJul 18, 2023Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341607 ↗
• MalfunctionMay 24, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE CART WAS FULL BUT READS EMPTY. BOTH CYLINDERS/SIDES HAD INCORRECT INFORMATION FOR THE FLUID VOLUME. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. NO ADVERSE EVENT IS ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16994549 ↗
• MalfunctionApr 11, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED UNIT IS NOT POWERING ON. THE MALFUNCTION DID NOT OCCUR DURING SURGERY. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. AT PRODUCT EVALUATION INVESTIGATION THE UNIT WOULD NOT POWER ON AS THE POWER INLET MODULE WAS SINGED DUE TO THE FUSES SHORTING OUT. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718409 ↗
• MalfunctionMar 16, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THE UNIT WILL NOT TURN ON. THE EVENT DID NOT OCCUR DURING SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. THE DEVICE EVALUATION DISCOVERED THE POWER INLET MODULE WAS BURNT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552119 ↗
• MalfunctionMar 9, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE UNIT WAS SHOWING WASH VALVE ERROR. THE ISSUE OCCURRED OUTSIDE THE SURGICAL ENVIRONMENT WITH NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. AT PRODUCT EVALUATION INVESTIGATION THE INSULATION ON THE POWER CORD WAS TORN. THE WIRING WAS EXPOSED. NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16512152 ↗
• MalfunctionMar 7, 2023Circuit Failure; Material Frayed; Circuit Failure; Material Frayed

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16499195 ↗
• MalfunctionMar 1, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE UNIT WILL NOT TURN ON. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. UPON INVESTIGATION, THE POWER CORD WAS BURNED. DUE DILIGENCE IS COMPLETE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460117 ↗
• MalfunctionJan 19, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THERE WAS NO POWER AT ALL. CHANGED CORDS AND STILL NO POWER. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION FOUND EVIDENCE OF MELTING AND BLISTERING ON THE FUSE PORTS. THERE WAS ALSO BURNS AND CHAR ON THE FUSE PORTS BUT THERE WAS NO SMOKE. 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 16209451 ↗
• MalfunctionDec 27, 2022Fire; Fire

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050420 ↗
• MalfunctionAug 9, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CART IS READING FULL WHEN ITS ACTUALLY EMPTY. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO HARM OR DELAY REPORTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190614 ↗
• MalfunctionJul 28, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT THE POWER INLET MODULE AND THE POWER CORD WERE BURNT. THERE WAS NO SMOKE, HOWEVER, THERE WERE SIGNS OF ARCHING. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. 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 15120149 ↗
• MalfunctionJun 22, 2022Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up

  IT WAS REPORTED THAT THE DEVICE HAS NO POWER. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FOUND BY THE INVESTIGATION THAT THE DEVICE WAS MELTED AND IT WAS FURTHER REPORTED THAT THE DEVICE HAD EVIDENCE OF BURN/CHAR ON IT, HOWEVER, THERE WAS NO SMOKE. 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 14774282 ↗
• MalfunctionMay 18, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT BEFORE SURGERY THERE WAS A POWER INLET MODULE FAILURE AND THE UNIT WOULD NOT POWER ON. AT PRODUCT EVALUATION INVESTIGATION THE POWER INLET MODULE HAD SLIGHT BURNING AND CHARRING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14427942 ↗
• MalfunctionMay 9, 2022No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THIS UNIT IS RECEIVING VACUUM SENSOR ERRORS. THE EVENT TIMING WAS DURING CLEANING. NO PATIENT INVOLVEMENT OR HARM. IN THE REPAIR RECORD, IT WAS FOUND THAT THE POWER INLET WAS BURNT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14335903 ↗
• MalfunctionMar 24, 2022Material Discolored; Melted; Failure to Power Up; Material Deformation; Material Discolored; Melted; Failure to Power Up; Material Deformation

  IT WAS REPORTED THAT DURING CLEANING THE UNIT WILL NOT TURN ON. THE FUSE BLOCK IS MELTED AND DEFORMED AND THE POWER CORD PLUG IS BURNED AND DISCOLORED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13890328 ↗
• MalfunctionAug 13, 2021Decrease in Suction; Smoking; Decrease in Suction; Smoking

  IT WAS REPORTED THE UNIT HAS WEAK SUCTION AFTER SURGERY. UPON TECH INSPECTION, BOTH IN-LINE FILTERS AND HEPA FILTER WERE DIRTY FROM THE ACCOUNT PULLING SMOKE INTO THE CART. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12318138 ↗
• MalfunctionJul 9, 2021Fire; Fire

  IT WAS REPORTED THAT THE CART WOULD NOT POWER ON AND THE INLET MODULE SHOWED SIGNS OF HEAT DAMAGE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145690 ↗
• MalfunctionApr 14, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING INSTALL/PM TORN INSULATION ON THE WIRES FROM THE POWER INLET MODULE TO THE BOARD WAS FOUND. THERE WAS EXPOSED WIRE, HOWEVER NO HARM TO PATIENT OCCURRED AND NO OTHER ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667329 ↗