IntelliCart™ 00-5140-109-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00889024466012), received between Jan 15, 2020 and May 19, 2026 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (6 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.

• MalfunctionMay 19, 2026Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE IS SMOKING FROM BEHIND. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222804 ↗
• InjuryNov 12, 2025Unstable; Unstable

  THERE WAS NO ADDITIONAL INFORMATION ASSOCIATED WITH THIS EVENT.

  Patient problems: Graft failure; Insufficient Information

  MAUDE report 23531961 ↗
• MalfunctionApr 21, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT HAD DAMAGED HOLES. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO FURTHER INFORMATION IS AVAILABLE. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT COUPLER HOSE SLEEVE HAD A TEAR EXPOSING THE HOSE AND WIRES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875419 ↗
• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAD A FLUID LEAK. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE DRAIN PUMP WAS LEAKING AND SMOKING. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707659 ↗
• MalfunctionAug 22, 2023Connection Problem; No Apparent Adverse Event; Connection Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE EVAC HAS A COMMUNICATION ERROR AND IS NOT COMMUNICATING WITH CARTS. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. THE EVALUATION FOUND THE NOSE BOARD WAS BURNT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17599431 ↗
• MalfunctionMar 16, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16555148 ↗
• MalfunctionJan 26, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE EVAC WAS NOT CONNECTING TO THE CARTS. UPON INSPECTION IT WAS NOTED THAT THE NOSE BOARD CONTACTS HAD ARCING. NO ADVERSE EVENTS ARE ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16250767 ↗
• MalfunctionSep 30, 2022Difficult to Flush; Material Frayed; Difficult to Flush; Material Frayed

  IT WAS REPORTED THAT THE UNIT IS NOT DRAINING AND THE WIRES ON THE COUPLER ARE EXPOSED. THE EVENT DID NOT OCCUR DURING SURGERY. NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15519513 ↗
• MalfunctionJun 9, 2022Fluid/Blood Leak; Incorrect Measurement; Fluid/Blood Leak; Incorrect Measurement

  IT WAS REPORTED THAT THE MACHINE READS NOT GETTING ENOUGH WATER, BUT IT'S FULL AND WATER IS ON THE FLOOR. LOOP BACK CHECK VALVE NEEDED TO BE REPLACED. FLUID VOLUME WAS INCORRECT IN BOTH CYLINDERS. THERE WAS NO PATIENT INVOLVEMENT AS IT DID NOT OCCUR DURING SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14643986 ↗
• MalfunctionMay 5, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE UNIT WAS CONFIRMED TO NOT CONNECT TO CARTS AND THE NOSE BOARD WAS FOUND TO HAVE A BURNT CONTACT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14292659 ↗
• MalfunctionMay 4, 2022Connection Problem; Connection Problem

  DURING CLEANING, DEVICE WOULD NOT CONNECT TO CARTS. UPON EVALUATION THE LEAK DETECTOR WAS NOTED TO BE BURNT AND SHORTED. NO HARM OR DELAY WERE REPORTED AS IT RELATES TO THIS EVENT. NO OTHER ADVERSE EVENTS WERE REPORTED ALONG WITH THIS. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14281810 ↗
• MalfunctionApr 29, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THE NOSE BOARD HAS BURNT CONTACT POINTS. THE EVENT TIMING WAS DURING CLEANING. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14251005 ↗
• MalfunctionApr 21, 2022Thermal Decomposition of Device; Corroded; Connection Problem; Thermal Decomposition of Device; Corroded; Connection Problem

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14168009 ↗
• MalfunctionMar 27, 2022Loose or Intermittent Connection; Excessive Heating; Loose or Intermittent Connection; Excessive Heating

  IT WAS REPORTED THIS EVAC WAS NOT CONNECTING TO THE CARTS. THE NOSE BOARD ON THE COUPLER WAS BURNT. NO HARM, INJURY, OR ADVERSE EVENT TO THE OPERATOR. THE TIMING WAS DURING CLEANING. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925213 ↗
• MalfunctionJun 16, 2021Image Display Error/Artifact; Connection Problem; Image Display Error/Artifact; Connection Problem

  IT WAS REPORTED THE CARTS INTERMITTENTLY WILL NOT CONNECT TO THIS UNIT AND THE UNIT IS ISSUING WATER VALVE ERRORS. THE EVENT TIMING WAS DURING CLEANING. THERE WAS NO HARM TO THE PATIENT. INVESTIGATION FOUND THE COUPLER HAD BURNT CONTACTS. THERE WAS NO ADVERSE EVENT REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12008656 ↗
• MalfunctionJun 15, 2021Electrical /Electronic Property Problem; Image Display Error/Artifact; Electrical /Electronic Property Problem; Image Display Error/Artifact

  IT WAS REPORTED THAT DURING CLEANING THIS EVAC WAS GIVING VALVE ERRORS AND HAVING COMMUNICATION ERRORS. INVESTIGATION FOUND THE COUPLER BOARD HAD BURNT CONTACTS. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997986 ↗
• MalfunctionApr 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE EVAC WAS GIVING BLEACH AND ENZYME EMPTY ERRORS WHEN NOT EMPTY. FLOW SENSOR NOT FUNCTIONING DURING CLEANING. THERE WAS NO HARM OR DELAY. INVESTIGATION SHOWED DAMAGED WIRES AND PHOTO SHOWED THEY WERE EXPOSED. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752754 ↗
• MalfunctionApr 27, 2021Melted; Melted

  IT WAS REPORTED THAT DURING CLEANING THE CART WOULD NOT CONNECT TO ANY CART. UPON INSPECTION IT WAS FOUND THAT THE CONTROL BOARD WAS CHARRED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732110 ↗
• MalfunctionMar 8, 2021Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THIS EVAC WAS HAVING NUMEROUS EVAC COMM ERRORS DURING CLEANING WHILE CONNECTING TO THE CART HE WAS WORKING ON. INVESTIGATION FOUND BURN MARKS ON THE COUPLER NOSE BOARD. THERE WERE NO ADVERSE EVENTS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11436653 ↗
• MalfunctionJan 28, 2020Material Frayed; Material Frayed

  IT WAS REPORTED THAT DURING CLEANING THE EVAC WAS LEAKING AND DID NOT RESULT IN HARM OR DELAY. THERE WERE EXPOSED WIRES. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9636098 ↗
• MalfunctionJan 15, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT POST-SURGERY THE UNIT WAS NOT READING THE FLUID LEVELS CORRECTLY. THERE WAS NO HARM AND NO DELAY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9590418 ↗