IntelliCart™ UE-5140-101-00Recalls & reported problems
Zimmer Orthopaedic Surgical Products, Inc. · Class 2
All models of IntelliCart (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zimmer Biomet IntelliCart portable suction unit is used to draw fluid during surgery. The 33 reports mostly describe the unit failing to power up, with burnt or melted power inlet modules and fuses, and some units showing the reservoir full when the cylinders were empty or giving error codes. No deaths or injuries were reported, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00889024466029), received between Feb 16, 2021 and Apr 13, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Failure to Power Up” (17 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.
Reports received per month
Most reported problems
Device problems
- Failure to Power Up17
- Thermal Decomposition of Device7
- Melted5
- Incorrect Measurement3
- Material Frayed3
- Smoking3
- Electrical /Electronic Property Problem2
- Material Integrity Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions34
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Smoking
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT STARTED SMOKING, BUT NO FIRE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24864942 ↗MalfunctionAug 24, 2023Melted; Failure to Power Up; Melted; Failure to Power Up
IT WAS REPORTED THAT OUTSIDE OF SURGERY THAT THE UNIT UNIT HAS NO POWER. AFTER EVALUATION IT WAS DETERMINED THAT THE POWER INLET MODULE AND FUSE WERE BURNT/MELTED. THERE WAS NO HARM OR INJURY TO THE PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17616953 ↗MalfunctionAug 24, 2023Melted; Failure to Power Up; Melted; Failure to Power Up
UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THIS MDR WAS NOT FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON MFR - 0001526350 - 2023 - 00975.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17611280 ↗MalfunctionJul 31, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT HAD NO POWER. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE. DURING PRODUCT EVALUATION INVESTIGATION IT WAS FOUND THAT THE POWER INLET MODULE HAD BLISTERING AND CHAR. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17427198 ↗MalfunctionJun 13, 2023Thermal Decomposition of Device; Circuit Failure; Thermal Decomposition of Device; Circuit Failure
NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17117227 ↗MalfunctionMay 24, 2023Difficult to Flush; No Apparent Adverse Event; Difficult to Flush; No Apparent Adverse Event
IT WAS REPORTED THE UNIT WILL NOT DRAIN AND IS GIVING A VALVE PACK ERROR. THE EVENT TIMING IS 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, THE FUSE BOX IS BURNT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16996552 ↗MalfunctionApr 6, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE UNIT WAS SHOWING FULL WHEN IT WAS EMPTY ON BOTH CYLINDERS. THE ISSUE DID NOT OCCUR DURING SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16691525 ↗MalfunctionMar 30, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT'S RES BOARD WAS READING FULL WHEN EMPTY AND BOTH CYLINDERS WERE AFFECTED. THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16646573 ↗MalfunctionMar 29, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE UNIT IS SHOWING RESERVOIR FULL WHEN IT IS NOT. CYLINDER 1 AND CYLINDER 2 WERE INDICATING RESERVOIR FULL INTERMITTENTLY. THE EVENT OCCURRED OUTSIDE THE SURGICAL ENVIRONMENT. NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16639206 ↗MalfunctionMar 27, 2023Thermal Decomposition of Device; Failure to Power Up; Smoking; Suction Problem; Noise, Audible; Thermal Decomposition of Device; Failure to Power Up; Smoking; Suction Problem; Noise, Audible
THERE IS NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16619649 ↗MalfunctionFeb 27, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT OUTSIDE THE SURGICAL ENVIRONMENT THIS CART HAD NO POWER. THERE WAS NO PATIENT INVOLVEMENT. AT PRODUCT EVALUATION, THE POWER INLET MODULE WAS BURNT OUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16443268 ↗MalfunctionFeb 1, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE SCREEN DOES NOT TURN ON. THE ISSUE WAS DISCOVERED OUTSIDE THE SURGICAL ENVIRONMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE POWER INLET MODULE AND POWER CORD WERE BURNT AND MELTED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16278330 ↗MalfunctionJan 10, 2023Failure to Power Up; Failure to Power Up
IT WAS REPORTED THE DEVICE DOES NOT TURN ON. THE EVENT OCCURRED OUTSIDE OF SURGERY AND THERE WAS NO PATIENT INVOLVEMENT. EVALUATION OF THIS DEVICE LATER FOUND THAT THE FUSE DRAWER WAS BURNED/BLISTERED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16132736 ↗MalfunctionJan 9, 2023Suction Failure; Suction Failure
IT WAS REPORTED THAT THIS UNIT HAS NO SUCTION. THIS ISSUE WAS DISCOVERED OUTSIDE THE SURGICAL ENVIRONMENT. THUS, NO HARM OR DELAY WAS REPORTED. AT PRODUCT EVALUATION INVESTIGATION THE POWER INLET MODULE WAS FOUND BURNED IN BOTH FUSE PORTS. NO ADDITIONAL EVENT INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16120695 ↗MalfunctionDec 6, 2022Fluid/Blood Leak; Material Frayed; Fluid/Blood Leak; Material Frayed
IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS LEAKING FROM THE BOTTOM AND THERE WERE WIRES EXPOSED AND SHOWING. NO HARM OR DELAY WERE REPORTED AS NO PATIENT INVOLVEMENT WAS NOTED. NO ADVERSE EVENT WAS REPORTED AS IT RELATES TO THE EVENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15927709 ↗MalfunctionDec 6, 2022Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE UNIT WOULD NOT POWER ON. THE EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION FOUND EVIDENCE OF BURNS AND BLISTERS ON THE FUSE DRAWER. 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 15923089 ↗MalfunctionNov 7, 2022Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
IT WAS REPORTED THAT THE POWER CORD WAS CUT AND THERE WERE EXPOSED WIRES. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO HARM OR DELAY REPORTED AS THERE WAS NO PATIENT INVOLVEMENT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15749030 ↗MalfunctionOct 20, 2022Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT THE UNIT DOES NOT POWER ON. 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 UPON INVESTIGATION, THERE WERE SIGNS OF CHARRING ON THE POWER SUPPLY BOARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15641668 ↗MalfunctionOct 13, 2022Device Displays Incorrect Message; Device Displays Incorrect Message
IT WAS REPORTED THAT THE UNIT WAS HAVING A COUNTING ISSUE, IT WASN'T WORKING ON EITHER SIDE. THERE WAS NO HARM OR DELAY REPORTED. THE EVENT TIMING WAS DURING CLEANING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15598674 ↗MalfunctionOct 3, 2022Melted; Failure to Power Up; Melted; Failure to Power Up
IT WAS REPORTED THAT THE POWER CORD MELTED. THE EVENT TIMING WAS OUTSIDE OF SURGERY. THERE WAS NO HARM OR DELAY REPORTED. UPON INVESTIGATION, IT WAS FOUND THAT THE POWER INLET MODULE AND POWER CORD WERE BURNT AND MELTED, THE FUSES WERE SHORTED OUT, THE FUSE PORTS WERE BLISTERED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15527922 ↗MalfunctionAug 17, 2022Material Frayed; Material Frayed
IT WAS REPORTED THAT THE WYE POWER CORD ON THIS UNIT HAS EXPOSED WIRES. THE EVENT TIMING WAS OUTSIDE OF SURGERY. NO ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15241156 ↗MalfunctionAug 1, 2022Thermal Decomposition of Device; Failure to Power Up; Thermal Decomposition of Device; Failure to Power Up
IT WAS REPORTED THAT THE UNIT WAS NOT POWERING ON AND THE INLET MODULE IS BURNT. THE ISSUE 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 15138624 ↗MalfunctionMay 26, 2022Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up
IT WAS REPORTED THAT PRIOR TO SURGERY THE CART WAS NOT WORKING. CART WOULD NOT START, AND THE SCREEN WAS BLACK. THERE WAS NO HARM OR DELAY REPORTED. DURING DEVICE EVALUATION, IT WAS NOTED THAT THE BOTTOM METAL SHIELDING HAD BURNED/WARPED FROM OVERHEATING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14518256 ↗MalfunctionMay 7, 2022Failure to Power Up; Failure to Power Up
IT WAS REPORTED THAT DURING CLEANING THIS CART WOULD NOT TURN ON. PRODUCT EVALUATION INDICATED THAT THE POWER INLET MODULE FUSE DRAWER WAS MELTED WITH NO OTHER SIGNS OF BURNING/CHARRING/ARCING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14315343 ↗MalfunctionApr 29, 2022Thermal Decomposition of Device; Material Integrity Problem; Thermal Decomposition of Device; Material Integrity Problem
IT WAS REPORTED THAT THIS CART HAD A BURNT POWER INLET MODULE AND CORDS. THE EVENT TIMING WAS PRIOR TO SURGERY. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14249785 ↗
Other APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED devices
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- Penumbra System PMX220Penumbra, Inc. · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED102 reports
- DeVilbiss 7314P-DDevilbiss Healthcare LLC · Apparatus, Suction, Ward Use, Portable, Ac-Powered69 reports
- PIRANHA 2208011Richard Wolf GmbH · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED54 reports
- Neptune 0770100000Stryker Corporation · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED1 recall0 reports
- LCSU 4, 800 ml, RTCA Complete Unit 880052Laerdal Medical AS · Apparatus, Suction, Ward Use, Portable, Ac-Powered1 recall0 reports
- Neptune 0711001000Stryker Corporation · APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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