MESHGRAFT™ 00-2195-001-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00889024372535), received between Apr 13, 2021 and Jul 9, 2026 — classified as 25 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (19 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Retraction Problem

  IT WAS REPORTED THAT THE DURING KIT INSPECTION, THE RATCHET HANDLE DOES NOT PERFORM THE UP OR DOWN. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25761843 ↗
• MalfunctionNov 24, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE BACK-AND-FORTH MECHANISM WAS DEFECTIVE. IT DAMAGES THE GRAFT AND DOES NOT ALLOW IT TO BE MOVED BACKWARD (THE HANDLE). PATIENT IMPACT IS UNKNOWN. 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: Graft failure

  MAUDE report 23632430 ↗
• MalfunctionNov 13, 2025Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543264 ↗
• MalfunctionNov 13, 2025Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543256 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367670 ↗
• MalfunctionOct 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN EVENT DATE. TEST GRAFTS SHOWED ¿SKIPPING¿ IN THE RESULTS. THE MESHER IS DISENGAGING AT CERTAIN POINTS DURING USE. IT IS UNKNOWN WHETHER THERE WAS ANY PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23366715 ↗
• MalfunctionJul 30, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED DURING SURGERY, THE UNIT DOES NOT PROPERLY MESH. THERE WAS NO PATIENT HARM. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE GRAFT WAS NOT DAMAGED, AND AN ADDITIONAL SKIN GRAFT WAS NOT REQUIRED TO COMPLETE THE SURGERY. THERE WAS NO SURGICAL DELAY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22666905 ↗
• MalfunctionJul 8, 2025Failure to Cut; Unintended Movement; Failure to Cut; Unintended Movement

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS SHOWING ¿SKIPPING¿ IN THE RESULTS. MESHER WAS DISENGAGING AT CERTAIN POINTS DURING USE. THE DEVICE WAS TESTED MULTIPLE TIMES TO VERIFY CALIBRATION AND IT WAS MISSING CUTS DURING TESTING FROM CUSTOMER. IT WAS CONFIRMED THAT MESHER WAS TESTED PRIOR TO USE IN HARVESTED TISSUE SO NO DAMAGE CAUSED TO TISSUE AN ALTERNATE MEANS OF PREPARING THE GRAFT WAS UTILIZED. THERE WAS NO PATIENT HARM OR DELAY. DUE DILIGENCE IS COMPLETE.

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

  MAUDE report 22438007 ↗
• MalfunctionJul 1, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE CANNOT MESH PROPERLY. THERE WAS NO PATIENT IMPACT OR DELAY. THE TAKEN GRAFT WAS DAMAGED BUT AN ADDITIONAL GRAFT WAS NOT NEEDED. ANOTHER DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22378567 ↗
• MalfunctionMay 2, 2025Failure to Cut; Failure to Cut

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21951281 ↗
• MalfunctionSep 26, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING KIT INSPECTION, THE UNIT DID NOT PROPER MESH. 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 20312056 ↗
• MalfunctionJul 23, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING KIT INSPECTION THE DEVICE DID NOT MESH PROPERLY. 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 19812516 ↗
• MalfunctionJul 2, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING KIT INSPECTION THE UNIT DID NOT MESH PROPERLY. 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 19655913 ↗
• MalfunctionMar 15, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING KIT INSPECTION THE DEVICE WOULD NOT MESH PROPERLY. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE INFORMATION COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912510 ↗
• MalfunctionFeb 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO SURGERY, INSTRUMENT WAS TOO TIGHT. FOLLOW-UP CONFIRMED DIFFICULT TO ADVANCE/ STUCK. THERE WAS NO PATIENT INVOLVEMENT, IMPACT, OR DELAY SINCE EVENT OCCURRED PRIOR TO SURGERY. DUE DILIGENCE INFORMATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18759514 ↗
• MalfunctionDec 4, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING KIT INSPECTION THE RATCHET HANDLE DOES NOT MOVE UP OR DOWN. 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 18256028 ↗
• MalfunctionAug 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS IN NEED OF REPAIR FOR AN UNKNOWN REASON. THERE IS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT. 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 17603801 ↗
• MalfunctionMay 23, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT UNIT DOES NOT PROPER MESH. THE EVENT TIMING WAS DURING SURGERY. THERE IS NO HARM OR DELAY REPORTED. ANOTHER PRODUCT WAS USED TO FINISH THE SURGERY.NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTIONDUE DILIGENCE IS COMPLETE AND NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16986831 ↗
• MalfunctionMay 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16901648 ↗
• MalfunctionJan 31, 2023Failure to Cut; Naturally Worn; Failure to Cut; Naturally Worn

  IT WAS REPORTED THAT MALFUNCTION OCCURRED DURING SURGERY. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO DELAY. THE TAKEN GRAFT WAS DAMAGED BUT ANOTHER UNPLANNED GRAFT WAS NOT TAKEN. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271224 ↗
• MalfunctionNov 18, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE GRAFT MESHER MADE LINES IN THE GRAFT INSTEAD OF HOLES. THERE WAS NO HARM OR DELAY REPORTED. DILIGENCE IS IN PROCESS AND TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825877 ↗
• MalfunctionOct 20, 2022Failure to Cut; Failure to Cut

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15638131 ↗
• MalfunctionApr 12, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THE GRAFT INSTRUMENT DIDN'T MESH HALFWAY THROUGH. THE TIMING OF EVENT WAS DURING SURGERY. THERE WAS NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14083062 ↗
• MalfunctionApr 6, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT AT INSTRUMENT CHECK PRIOR TO THE SURGERY THE ROLLER OF THE DEVICE WAS FOUND TO BE DEFECTIVE AND NO LONGER CUTS CORRECTLY. 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 14022419 ↗
• MalfunctionApr 13, 2021Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT THE DEVICE WOULD NOT CUT INTO THE SKIN. EVENT OCCURRED DURING INSPECTION AT THE HOSPITAL'S STERILIZATION AND DISINFECTION DEPARTMENT. NO PATIENT INVOLVEMENT. INVESTIGATION FOUND THE CUTTERS FAILED THE CUT TEST. NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11655307 ↗