N/A 00-7703-015-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 206 adverse event reports that list this exact device (DI 00889024375444), received between Dec 4, 2020 and Sep 23, 2026 — classified as 1 injury, 205 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (151 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 206 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Failure to Cut

  It was reported that skingraft mesher doesn't make smooth holes for grafts. There is no information provided regarding the timing of the event or if there was any patient involvement/harm that may have occurred. During device evaluation, it was discovered that the cutter failed the sample mesh test. Due diligence is complete as multiple attempts were made; however, no further information is available. As no additional information is available, we are unable to provide further information.

  Patient problems: Insufficient Information

  MAUDE report 50869133 ↗
• MalfunctionJul 9, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE GRAFT KEEPS STICKING TO THE BLADES. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DURING THE INVESTIGATION THE CUTTER FAILED THE SAMPLE MESH TEST DURING EVALUATION. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25766157 ↗
• MalfunctionApr 28, 2026Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN TIME, THE DEVICE HAD A DAMAGE BLADE COMB. IT IS UNKNOWN IF THERE WAS PATIENT INJURY, OR DELAY. DURING THE INVESTIGATION, IT WAS FOUND THAT THE CUTTERS FAILED THE CUT TEST. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25016168 ↗
• MalfunctionApr 23, 2026Failure to Cut

  IT WAS REPORTED THAT THE UNIT WAS NOT MESHING. THERE IS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT OR IF THERE WAS ANY PATIENT INVOLVEMENT/HARM THAT MAY HAVE OCCURRED. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO DAMAGE .DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24967508 ↗
• MalfunctionApr 8, 2026Failure to Cut; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE'S 1.0-1.5 CUTTER WAS NOT CUTTING SKIN AND WAS STUCK IN THE MACHINE. THE HOSPITAL WAS ABLE TO FREE THE STUCK CUTTER FROM THE MACHINE GRAFT HARVESTED AND NURSES AND SURGEON HAD ISSUES WITH MESHING MULTIPLE SHEETS OF SKIN. CUTTER WAS NOT UNIFORMLY CUTTING INTO THE SKIN AND WAS NOT CUTTING ALL THE WAY THROUGH. SURGEON HAD TO COMPLETE THE MESHING OF THE SHEETS OF SKIN WITH A BLADE BEFORE BEING ABLE TO APPLY GRAFT TO PATIENT. AT THE END OF THE SURGERY NURSING STAFF UNABLE TO OPEN THE PINS TO REMOVE THE CUTTING INSERT. MESHER SENT TO MDRD WITH CUTTING TOOL STILL INSIDE. THERE WAS NO NOTE OF PATIENT IMPACT THERE WAS BUT THERE WAS A DELAY, THE SURGERY TOOK LONGER THAN EXPECTED APPROXIMATE 30 MINUTES DUE TO ADDITIONAL STEPS NEEDED TO CUT INTO THE GRAFTS BEFORE APPLYING TO PATIENT. THERE WAS NO OTHER GAFT NEED IT, SURGEON USED GRAFTS ALREADY HARVESTED BUT HAD TO COMPLETE THE MESHING BY HAND. DUE DILIGENCE IS COMPLETED; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24817867 ↗
• MalfunctionNov 21, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE MESHER PLATE WAS DAMAGED, AND THE CUTTERS WERE WORN DOWN. AFTER FINAL INVESTIGATION, IT WAS CONFIRMED THAT THIS CUTTER FAILED THE CUT TEST. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23619424 ↗
• MalfunctionOct 28, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE THE CUTTER FAILED THE TEST CUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23406135 ↗
• MalfunctionAug 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE AND WRENCH NEEDED TO BE CHECKED. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22853135 ↗
• MalfunctionJul 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THEY WERE UNABLE TO OPEN THE UNIT TO REMOVE THE CUTTER/PLASTIC. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22576606 ↗
• MalfunctionJul 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS FOUND IN NEED OF REPAIR. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576536 ↗
• MalfunctionJul 15, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING DECONTAMINATION IT WAS DETERMINED THAT THE CUTTER WAS NEEDED TO BE SENT IN FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER DID NOT PASS THE MESH TEST. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22513188 ↗
• MalfunctionJun 26, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT BEFORE SURGERY, THE UNIT WAS STUCK AND DID NOT OPEN AND THE HANDLE WAS NOT ABLE TO PERFORM THE UP AND DOWN MOTION. THE CUTTER FAILED THE CUT TEST AFTER FINAL INVESTIGATION. THERE IS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED TO THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337408 ↗
• InjuryMay 30, 2025Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, UNEVEN MESHED GRAFT OBTAINED FROM DEVICE. THE GRAFT WAS UNUSABLE. THERE WAS AN ADDITIONAL UNPLANNED GRAFT TAKEN AND A DELAY OF 30 MINUTES, ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. AFTER FINAL INVESTIGATION IT WAS FOUND THAT THE CUTTER COULD HAVE CONTRIBUTED TO THE REPORTED EVENT AS IT FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Laceration(s)

  MAUDE report 22113692 ↗
• MalfunctionApr 23, 2025Prophylactic removal due to corrective action; Prophylactic removal due to corrective action

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE WAS SENT IN FOR PREVENTIVE MAINTENANCE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. 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 21891792 ↗
• MalfunctionMar 20, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE CUTS WERE UNEVEN ON ONE SIDE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE UNIT COULD NOT PERFORM A PROPER MESH AND REPLACED IT. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21657543 ↗
• MalfunctionFeb 6, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING TESTING THE DEVICE MESHED INCORRECTLY. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. DURING DEVICE EVALUATION THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322743 ↗
• MalfunctionJan 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING DECONTAMINATION OR STERILIZATION PROCESSING THE MESHER WAS NOT WORKING PROPERLY. THERE WAS NO HARM OR DELAY REPORTED AS THE EVENT TIMING WAS WHEN NO PATIENT WAS INVOLVED. AN ALTERNATE DEVICE WAS AVAILABLE. DILIGENCE IS COMPLETE. AT DEVICE EVALUATION THE CUTTER FAILED THE SAMPLE MESH TEST DURING EVALUATION DUE TO AN INCOMPLETE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21282919 ↗
• MalfunctionJan 9, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY THE SURGEON WENT TO LOAD SPECIMEN INTO MESHER AND COULD NOT CONTINUE DUE TO IT BINDING UP. THERE IS NO HARM OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE. UPON INVESTIGATION, THE CUTTER WAS STUCK AND FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE CUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112190 ↗
• MalfunctionDec 12, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE ORIGINALLY AND FOUND TO BE NEEDING REPAIRED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. DURING DEVICE EVALUATION THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO AN INCOMPLETE MESH. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20915985 ↗
• MalfunctionDec 4, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE 1:5 ROLLER IS NOT WORKING. THERE IS NO PATIENT HARM. NO DELAY WAS REPORTED. DUE DILIGENCE IS COMPLETE AS THERE IS NO ADDITIONAL INFORMATION AVAILABLE. UPON INVESTIGATION, THE CUTTER FAILED THE CUT TEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842889 ↗
• MalfunctionNov 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEVICE WAS IN NEED OF REPAIR. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER WAS BLUNT AND FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20748320 ↗
• MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PRODUCT WAS NOT IN USE AND WAS SENT IN FOR PREVENTATIVE MAINTENANCE. THERE WAS NO HARM OR INJURY TO PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. THE MESHER WAS FOUND TO HAVE A DAMAGED COMB, AND CUTTER WAS NOTED TO BE DEFECTIVE. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION THE CUTTER FAILED THE TEST CUT. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20519277 ↗
• MalfunctionSep 16, 2024Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225816 ↗
• MalfunctionSep 13, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE PRODUCT WAS NOT IN USE AND WAS SENT IN FOR PREVENTATIVE MAINTENANCE. THERE WAS NO EVENT OR MALFUNCTION THAT LED TO THE DEVICE BEING SENT FOR PM. THERE WAS NO HARM OR INJURY TO PATIENT AS THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE CUTTER FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213033 ↗
• MalfunctionSep 11, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THAT THE CUTTER IS STUCK INSIDE THE MESHER. THERE WAS NO HARM, INJURY, OR DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE CUTTER FAILED THE SAMPLE MESH TEST DUE TO DAMAGE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20191716 ↗