PSI-TEC III Aspirator, 110V PT-ASP-III-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00081317023364), received between Feb 23, 2018 and Aug 11, 2025 — classified as 5 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Failure to Power Up” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Leak/Splash; Component Missing; Leak/Splash; Component Missing

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V WAS FOUND TO BE MISSING COMPONENTS AND LEAKING FROM THE BODY CONTOUR DURING AN OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22777544 ↗
• MalfunctionDec 20, 2023Device Emits Odor; Device Emits Odor

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V BEING USED IN AN UNSPECIFIED PROCEDURE WAS FOUND TO HAVE A ¿BURNING SMELL¿ DURING USE. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT; NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18366102 ↗
• InjuryAug 29, 2023Leak/Splash; Defective Component; Leak/Splash; Defective Component

  IT WAS REPORTED THAT A MENTOR PSI-TEC III ASPIRATOR, 110V HAS TECHNICAL ISSUE AND BYRON LIPOSUCTION PUMP FLOODED WITH BLOOD AND THEY REQUIRE TECHNICAL SUPPORT. NO PATIENT CONSEQUENCES OR ADVERSE EVENT REPORTED. FOLLOW-UPS ARE PERFORMED, IF ADDITIONAL INFORMATION RECEIVED, SUPPLEMENTAL REPORT WILL BE ADDED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647044 ↗
• MalfunctionAug 29, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PSI-TECIII ASPIRATOR 110V,STND WAS FOUND TO BE MECHANICALLY FAULTY DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647007 ↗
• MalfunctionAug 29, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V MACHINE WILL NOT TURN ON. NO PATIENT CONSEQUENCES OR PROCEDURAL DELAYS WERE REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641465 ↗
• MalfunctionAug 10, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PSI-TECIII ASPIRATOR 110V,STND WAS FOUND TO BE MECHANICALLY FAULTY DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY ANY PATIENT AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17502494 ↗
• InjuryMar 3, 2023Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR MALFUNCTIONED AS A FUSE BURNED OUT DURING AN UNSPECIFIED PROCEDURE. NO INFORMATION REGARDING PATIENT INVOLVEMENT WAS MENTIONED. AS A RESULT, A SERVICE REQUEST IS PENDING FOR REPAIR OF THE DEVICE. ALTHOUGH, MENTOR HAS NOT RECEIVED THE SERVICE REPORT OR THE DEVICE FOR REPAIR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16480900 ↗
• MalfunctionDec 14, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V WAS UNABLE TO BE USED DURING THE OPERATION DUE TO ELECTRICAL ISSUES (BLOWN FUSES). NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT. NO DELAYS IN SURGERY WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982334 ↗
• MalfunctionOct 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V WAS BEING USED IN A PROCEDURE DURING WHICH FLUID WAS SUCKED INTO THE UNIT. THERE WERE NO PATIENT CONSEQUENCES OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15596827 ↗
• MalfunctionSep 30, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, A PSI-TECIII ASPIRATOR WAS FLOODED WITH BIOHAZARD MATERIAL. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15514113 ↗
• MalfunctionAug 16, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT DURING AN UNSPECIFIED BLADDER SURGERY, A PSI-TEC III ASPIRATOR, 110V DEVICE WOULD NOT POWER ON. IT WAS REPORTED THAT GREEN LIGHTS TURNED ON, BUT COULD NOT HEAR THE DEVICE START UP. THE GREEN LIGHTS THEN FADED. A DIFFERENT OUTLET AND A DIFFERENT POWER CORD WERE USED, BUT THE DEVICE WOULD STILL NOT POWER ON. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15236903 ↗
• MalfunctionJul 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A 110V PSI-TEC III ASPIRATOR EXPERIENCED BACKED UP CONTENTS WITHIN THE MACHINE. WITHIN MINUTES OF TURNING ON THE ASPIRATOR, THE LIPOSUCTION FAT HAD BACKED UP INTO THE TUBING LEADING TO THE BACKUP FILTER AND INVADING THE INSIDE THE BASE OF THE UNIT. THE ASPIRATOR WAS THEN TURNED OFF AND THIS PART OF THE PROCEDURE STOPPED. THE FILLED FILTER PART OF THE ASPIRATOR WAS THEN REMOVED FROM SERVICE, CLEANED ON THE SURFACE AND SENT TO BIOMED FOR REPAIR AND INTERNAL CLEANING. ANOTHER ASPIRATOR WAS BROUGHT IN TO FINISH THE PROCEDURE. THERE WAS A 20-MINUTE DELAY. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14946239 ↗
• MalfunctionJul 6, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A 110V PSI-TEC III ASPIRATOR EXPERIENCED AN ELECTRICAL FAULT POST PROCEDURE. AT THE END OF SURGERY, THE UNIT TURNED OFF. DIFFERENT PLUGS AND OUTLETS WERE TRIED BUT IT WOULD NOT TURN BACK ON. NO PATIENT CONSEQUENCE AND NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940738 ↗
• MalfunctionMay 20, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V DEVICE POWERED OFF DURING AN UNSPECIFIED SURGERY. IT WAS DISCOVERED THAT A 15A 125V GMA FUSE HAD BLOWN. THE FUSE WAS REPLACED BUT THE DEVICE WOULD NOT POWER ON. IT WAS REPORTED THAT THERE WAS NO FLUID INVASION. NO PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14459572 ↗
• MalfunctionJan 12, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT PRIOR TO A PROCEDURE AN UNSPECIFIED FLUID WAS SUCKED INTO A 110V PSI-TEC III ASPIRATOR, AND IT WOULD NO LONGER OPERATE. THERE WAS NO REPORTED PATIENT CONTACT OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13240404 ↗
• InjuryJan 6, 2022Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT A PSI-TECIII ASPIRATOR 110V, STND COMPLETELY SHUT DOWN AND HAD NO POWER INTRA-OPERATIVELY. IT WAS INDICATED THAT THIS INCIDENT CAUSED INJURY TO THE PATIENT. FOLLOW-UPS WERE PERFORMED BUT NO ADDITIONAL INFORMATION WAS MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 13183549 ↗
• MalfunctionDec 29, 2021Device Emits Odor; Obstruction of Flow; Device Emits Odor; Obstruction of Flow

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR MALFUNCTIONED DURING AN UNSPECIFIED PROCEDURE. IT WAS OBSERVED THAT THERE WAS SOME PATIENT LIPID TISSUE LODGED WITHIN THE TUBING AND AN ODOR DESCRIBED AS A SMOKING SMELL WAS EMITTED FROM THE DEVICE. THERE WAS NO REPORTED DELAY TO THE PROCEDURE, OR ANY PATIENT CONSEQUENCES CAUSED BY THE MALFUNCTION. AS A RESULT, A SERVICE REQUEST IS PENDING FOR REPAIR OF THE DEVICE. ALTHOUGH, MENTOR HAS NOT RECEIVED THE SERVICE REPORT OR THE DEVICE FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112975 ↗
• MalfunctionNov 29, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V LOST SUCTION DURING PROCEDURE. IT WAS REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES, NO SURGERY DELAY AND NO ADVERSE EVENT FOR THE PATIENT WERE REPORTED. DEVICE PENDING TO BE RETURNED FOR REPAIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12888185 ↗
• InjuryOct 14, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED VIA MEDWATCH NUMBER: (B)(4) THAT A PSI-TEC III ASPIRATOR, 110V HAS BEEN MALFUNCTIONING OUTSIDE OF SURGERY. THE NURSE REPORTED THE LIPO SUCTION MACHINE DIED WHILE TRYING TO USE IT ON THE RIGHT AXILLA. THE BIOMED TROUBLESHOOT THE MACHINE AND STATED THAT THE MOTOR WAS DEAD AND THE MACHINE IS OVER ELEVEN(11) YEARS OLD, NO INFORMATION WAS PROVIDED SUGGESTING ANY SURGICAL COMPLICATIONS OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12632776 ↗
• MalfunctionJul 16, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT, BEFORE AN UNKNOWN PROCEDURE, A PSI-TEC III ASPIRATOR, 110V WAS OBSERVED TO HAVE FLUID IN THE PUMP. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181670 ↗
• MalfunctionApr 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V BEING USED IN AN UNSPECIFIED PROCEDURE WAS FOUND TO HAVE SUCTION ISSUES (NO SUCTION PRESSURE) DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713052 ↗
• MalfunctionMar 22, 2021Filtration Problem; Filtration Problem

  IT WAS REPORTED THAT BLOOD HAD GOTTEN PAST THE SECONDARY FILTER OF A PSI-TEC III ASPIRATOR, 110V DEVICE. THE PORT WAS SWABBED AND BLOOD WAS FOUND INSIDE THE UNIT.

  Patient problems: Insufficient Information

  MAUDE report 11547701 ↗
• MalfunctionDec 30, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V BEING USED IN AN UNSPECIFIED PROCEDURE WAS FOUND TO HAVE SUCTION ISSUES AND WOULD ONLY REACH 12 INCHES OF MERCURY (INHG) DURING THE OPERATION. NO ADVERSE EVENT WAS EXPERIENCED BY THE PATIENT, AND THERE WERE NO REPORTED PATIENT CONSEQUENCES OR PROCEDURAL DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098107 ↗
• MalfunctionAug 18, 2020Power Problem; Power Problem

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V SHUT DOWN DURING PROCEDURE. IT WAS REPORTED THAT THE FUSES WERE CHECKED, AND WERE VERIFIED TO BE BLOWN. THEY ATTEMPTED TO RESOLVE THE ISSUE BY REPLACING THE FUSES; HOWEVER, THE ISSUE PERSISTS. NO INFORMATION WAS PROVIDED SUGGESTING ANY SURGICAL COMPLICATIONS OR PROCEDURAL DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420434 ↗
• MalfunctionFeb 20, 2020Power Problem; Appropriate Device Problem Term/Code Not Available; Power Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PSI-TEC III ASPIRATOR, 110V HAS BEEN MALFUNCTIONING OUTSIDE OF SURGERY. THE PHYSICIAN REPORTED THAT THE FUSES KEEP POPPING, AND THAT THE DEVICE APPEARS TO SHORT OUT DURING USAGE BEFORE STOPPING COMPLETELY. THEY ATTEMPTED TO RESOLVE THE ISSUE BY CHANGING THE FUSES; HOWEVER, THE ISSUE PERSISTS. NO INFORMATION WAS PROVIDED SUGGESTING ANY SURGICAL COMPLICATIONS OR PROCEDURAL DELAYS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9735402 ↗