MESHGRAFT™ 00-2195-000-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00889024372528), received between Jan 21, 2022 and Feb 17, 2026 — classified as 3 injuries, 38 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (35 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE DEVICE DID NOT CUT THROUGH AT ALL PLACES. THERE WAS NO PATIENT INJURY, OR DELAY. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370562 ↗
• MalfunctionDec 9, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEVICE UNEVENLY SCORERS THE SKIN. NO EFFECT ON THE PATIENT'S CONDITION, SKIN WAS NOT INCISED DEEPLY ENOUGH. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23756553 ↗
• MalfunctionDec 8, 2025Loose or Intermittent Connection; Failure to Advance; Failure to Cut; Loose or Intermittent Connection; Failure to Advance; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE MESHER DOESN¿T CUT THROUGH IN ALL PLACES. IT ¿CHEWS¿ WHEN IT¿S SUPPOSED TO DRIVE THE PLATE FORWARD, AND SOMETIMES IT DOESN¿T GRAB THE PLATE AT ALL. IT FEELS LOOSE ACCORDING TO THE DOCTOR. PATIENT IMPACT IS UNKNOWN. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

  Patient problems: Graft failure; Insufficient Information

  MAUDE report 23741677 ↗
• MalfunctionOct 8, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT WAS NOT MESHING CLEAN, IT NEEDED TO BE SHARPENED. THERE WAS NO INFORMATION AVAILABLE REGARDING THE PATIENT IMPACT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23246924 ↗
• MalfunctionJul 23, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS NOT CUTTING GRAFT FULLY, DOCTOR HAD TO DO IT MANUALLY. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR SURGICAL DELAY. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22578361 ↗
• MalfunctionJul 17, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING UNKNOWN TIMING, THE UNIT WAS ONLY MESHING TISSUE ON THE EDGES AND NOT THE ENTIRE PIECE OF SKIN. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22533639 ↗
• MalfunctionJul 14, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT AT UNKNOWN EVENT TIMING, THE UNIT WAS ONLY MESHING TISSUE ON THE EDGES AND NOT THE ENTIRE PIECE OF SKIN. IT WAS NOT TAKING CLEAN SKIN GRAFTS. THERE WAS NO PATIENT HARM. DUE DILIGENCE IS COMPLETE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22495068 ↗
• MalfunctionJul 7, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT MESHES UNEVENLY, BARELY ENGAGES IN THE MIDDLE. 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 22412230 ↗
• InjuryMay 21, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE WHICH RECENTLY UNDERWENT PREVENTIVE MAINTENANCE, WAS NOT FUNCTIONING PROPERLY: WHEN USING THE DEVICE IT WOULD MAKE THE CUTS/SCORING IN A MAJORITY OF THE GRAFT BUT EVERY FEW INCHES WOULD SKIP A SECTION WHERE YOU CAN SEE THE INDENT WHERE IT WAS GOING TO CUT BUT THE CUT WAS NOT COMPLETED. WHEN DOING A LONGER GRAFT THIS "SKIPPED" PORTION WOULD COME UP ALMOST AT EQUAL DISTANCE. MEDICAL INTERVENTION/ADDITIONAL SURGICAL PROCEDURE WAS REQUIRED AS THE GRAFT WAS DAMAGED AND IN THAT AREA THE SURGEON DISCARDED OR WORKED AROUND, SCORED/CUT IT HIMSELF IF NEEDED. DUE DILIGENCE IS COMPLETED AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Graft failure

  MAUDE report 22064321 ↗
• MalfunctionMar 20, 2025Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT AT AN UNKNOWN TIMING THE HANDLE OF THE MESHER DID NOT FIT WELL ONTO THE UNIT. PATIENT INVOLVEMENT/IMPACT AND ANY SURGICAL DELAY ARE UNKNOWN. NO ADDITIONAL INFORMATION AVAILABLE IS INDICATED. DILIGENCE IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 21652490 ↗
• MalfunctionMar 6, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT BEFORE SURGERY THE DEVICE WAS FOUND TO BE DEFECTIVE. PASSING THE SKIN GRAFT THROUGH THE MESHER, PRODUCED A SKIN GRAFT THAT WAS NOT OF THE REQUIRED QUALITY. THE SURGEON WAS ABLE TO UTILIZE THE SKIN GRAFT AND AN ADDITIONAL GRAFT WAS NOT REQUIRED. THERE WAS NO HARM OR DELAY REPORTED AS THERE WAS NO PATIENT INVOLVEMENT. 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 21535858 ↗
• MalfunctionFeb 12, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT DID NOT CUT EVENLY. THE GRAFT WAS UNEVENLY MESHED. THERE IS NO PATIENT IMPACT OR DELAY REPORTED. DUE DILIGENCE IS COMPLETE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THE MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21366474 ↗
• InjuryJan 22, 2025Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: Graft failure; Laceration(s)

  MAUDE report 21207680 ↗
• MalfunctionOct 11, 2024Dull, Blunt; Failure to Cut; Dull, Blunt; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE DEVICE WAS NONFUNCTIONAL AS IT NO LONGER CUT THE SKIN. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20426694 ↗
• MalfunctionJul 11, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE SKIN GRAFT MESHER WAS NOT CUTTING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT WITH NO REPORT OF HARM OR DELAY. 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 19721968 ↗
• MalfunctionJul 2, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING UNKNOWN TIMING MESHER WAS NOT EVEN, SKIN WRINKLES ON ONE SIDE. UNKNOWN PATIENT INVOLVEMENT OR IMPACT. DUE DILIGENCE INFORMATION COMPLETE AS NO ADDITIONAL INFORMATION INDICATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655001 ↗
• MalfunctionJun 18, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT FIRMLY ATTACH TO THE SKIN AND PROPERLY STRETCH THE SKIN. THERE WAS NO REPORT OF HARM OR DELAY. AN ALTERNATE DEVICE WAS AVAILABLE FOR IMMEDIATE USE. 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 19557223 ↗
• MalfunctionMay 28, 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 19405402 ↗
• MalfunctionDec 27, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN DATE THE DEVICE PRODUCED AN INCOMPLETE MESH. THE SKIN GRAFTS WERE NOT COMING OUT EVENLY MESHED. THERE WAS NO REPORT OF HARM OR DELAY. DUE DILIGENCE IS IN PROCESS. 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 18397775 ↗
• MalfunctionNov 21, 2023Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WOULD NOT MESH. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. 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 18181349 ↗
• MalfunctionNov 6, 2023Dent in Material; Dent in Material

  IT WAS REPORTED THE SEVERAL GROOVES ON FEED ROLLER WERE INDENTED. THERE WAS NO INFORMATION PROVIDED REGARDING THE TIMING OF THE EVENT OR IF THERE WAS ANY PATIENT INVOLVEMENT/HARM THAT MAY HAVE OCCURRED. DURING DEVICE INVESTIGATION, IT WAS DISCOVERED THAT THE UNIT FAILED THE TEST CUT. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074957 ↗
• MalfunctionNov 6, 2023Failure to Cut; Failure to Cut

  NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072803 ↗
• MalfunctionOct 23, 2023Break; Failure to Cut; Physical Resistance/Sticking; Break; Failure to Cut; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE HANDLE PERFORMED AS INTENDED. THERE WAS NO UNEXPECTED INTERVENTION SUCH AS SUTURES WERE NEEDED. AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NOT REQUIRED TO COMPLETE THE SURGERY. THE THREE GRAFTS TAKEN WERE A PART OF THE NORMAL PROCEDURE FOR THIS CASE. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993317 ↗
• MalfunctionSep 19, 2023Break; Component Missing; Failure to Cut; Material Twisted/Bent; Break; Component Missing; Failure to Cut; Material Twisted/Bent

  NO ADDITIONAL EVENT INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772119 ↗
• InjurySep 12, 2023Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE MESHGRAFT II WAS DEFECTIVE AND NEEDED TO BE REPAIRED. THE TAKEN GRAFT WAS DAMAGED AND AN ADDITIONAL UNPLANNED SKIN GRAFT WAS NEEDED. THERE WAS A SURGICAL DELAY BETWEEN 20 TO 30 MINUTES DUE TO THE REVISION OF SKIN GRAFTS, AND EXTENSION OF DAMAGED GRAFTS USING A COLD BLADE SCALPEL. THE PATIENT WAS UNDER ANESTHESIA DURING THE DELAY. THERE WAS NO OTHER PATIENT HARM/INJURY NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Abrasion; Laceration(s)

  MAUDE report 17732838 ↗