IntelliCart™ 00514010300Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00889024501621), received between May 26, 2022 and Jan 6, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Smoking” (9 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 16, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 6, 2026Fluid/Blood Leak; Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS SMOKING AND LEAKING WHEN IN USE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23981397 ↗
• MalfunctionOct 8, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  IT WAS REPORTED THAT DURING CLEANING, THE UNIT HAD AN OVERHEATING ALERT AND STARTED 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 23244620 ↗
• MalfunctionJul 11, 2025Overheating of Device; Smoking; Overheating of Device; Smoking

  THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22479345 ↗
• MalfunctionNov 12, 2024Smoking; Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY BLACK SMOKE WAS COMING FROM THE UNIT, AND IT IS NO LONGER WORKING. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20668865 ↗
• MalfunctionOct 15, 2024Melted; Failure to Power Up; Smoking; Melted; Failure to Power Up; Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WAS SMOKING, WON'T TURN ON, FUSE HOLDER IS MELTED AND IT DOES NOT WORK WHEN DOCKED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453999 ↗
• MalfunctionFeb 19, 2024Device Alarm System; Overheating of Device; Smoking; Device Alarm System; Overheating of Device; Smoking

  IT WAS REPORTED THAT THE UNIT IS GIVING AN OVERHEAT ALARM AND IS SMOKING. THE EVENT TIMING IS OUTSIDE OF SURGERY. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18735722 ↗
• MalfunctionJun 6, 2023Circuit Failure; Device Emits Odor; Circuit Failure; Device Emits Odor

  IT WAS REPORTED THAT THE UNIT HAD A BURNING SMELL. THERE WAS A FUSE BLOWN ON POWER INLET MODULE. THE EVENT TIMING WAS NOT DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE POWER INLET MODULE WAS BLISTERED DUE TO A BLOWN FUSE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070958 ↗
• MalfunctionMar 23, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE UNIT HAD POWER ISSUES AND A POWER INLET MODULE FAILURE. NO REPORTED CHARRING, SMOKE, ETC. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE POWER INLET MODULE WAS BURNT. THIS INVESTIGATION DISCOVERY LED TO THE FINAL ASSESSMENT BEING ALTERED TO A REPORTABLE MALFUNCTION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16599181 ↗
• MalfunctionFeb 28, 2023Fluid/Blood Leak; Smoking; Fluid/Blood Leak; Smoking

  IT WAS REPORTED THAT UNIT HAS A LEAK AND IT'S SMOKING AS WELL. THE EVENT OCCURRED OUTSIDE OF SURGERY. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16453555 ↗
• MalfunctionFeb 9, 2023Smoking; Smoking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE WAS SMOKING. NO ADVERSE EVENT IS 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 16342003 ↗
• MalfunctionFeb 6, 2023Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE POWER CORD WAS BURNT AND WAS UNUSABLE. NO ADVERSE EVENTS ARE ASSOCIATED WITH THIS MALFUNCTION. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304038 ↗
• MalfunctionJan 12, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT CART DISPLAYED A VACUUM PUMP ERROR OUTSIDE OF SURGERY. NO HARM OR DELAY WERE REPORTED AS NO PATIENT INVOLVEMENT WAS NOTED. NO ADDITIONAL EVENT INFORMATION AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CART WAS GIVING A VACUUM PUMP ERROR AND HAD NO SUCTION; BURNT VACUUM PUMP FUSE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16146137 ↗
• MalfunctionAug 2, 2022Incorrect Measurement; Obstruction of Flow; Failure to Clean Adequately; Incorrect Measurement; Obstruction of Flow; Failure to Clean Adequately

  IT WAS REPORTED THAT THE UNIT WOULD NOT SHOW THAT IT WAS EMPTY IN BOTH CYLINDERS AND THERE IS A PIECE HANGING IN TANK AS WELL. THERE WAS BIOBURDEN LEFT AFTER A CLEAN CYCLE DUE TO THE ACCOUNT NOT RUNNING THE SOAKS REGULARLY. 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 15146348 ↗
• MalfunctionJul 28, 2022Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  IT WAS REPORTED THAT THE POWER INLET MODULE WAS BURNT. THE EVENT TIMING WAS NOT DURING SURGERY. NO PATIENT INVOLVEMENT OR HARM. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121029 ↗
• MalfunctionJun 14, 2022Thermal Decomposition of Device; Circuit Failure; Thermal Decomposition of Device; Circuit Failure

  IT WAS REPORTED THAT OUTSIDE THE SURGICAL ENVIRONMENT IT WAS DISCOVERED THAT THE POWER INLET MODULE FUSE BURNT OUT. THE POWER INLET MODULE WAS BURNT WITH SCORCHING ON THE POWER INLET MODULE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14684897 ↗
• MalfunctionMay 26, 2022Material Frayed; Material Frayed

  IT WAS REPORTED THERE WERE EXPOSED WIRES AND A LEAKAGE CURRENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14517464 ↗