MeshgraftTM II Tissue Expansion System 00-2195-012-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00889024372559), received between Nov 28, 2023 and Aug 3, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Incorrect Measurement

  Patient problems: Insufficient Information

  MAUDE report 50117301 ↗
• MalfunctionMar 16, 2026Delivered as Unsterile Product

  No further event information is available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605054 ↗
• InjuryFeb 23, 2026Incorrect Measurement; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING SURGERY THE PLATE THAT WAS USED WAS A DIFFERENT SIZE THAN WHAT WAS INDICATED ON THE PACKAGING. THE INDICATED SIZE ON THE PACKAGE WAS 1.5:1 BUT IT WAS A 3:1 RATIO. THERE WAS A LARGER HOLE IN THE TAKEN GRAFT BUT THE GRAFT WAS UTILIZED ON THE PATIENT. THE TAKEN GRAFT DID NOT LOOK GOOD SEVERAL DAYS LATER AS IT WAS MUSHY AND SMELLED BAD. IT WAS TREATED WITH SALINE-SOAKED COMPRESSES FOR ONE WEEK WITH DRESSING CHANGES. THERE WAS NO DELAY IN THE PROCEDURE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Impaired Healing

  MAUDE report 24421732 ↗
• MalfunctionFeb 17, 2026Delivered as Unsterile Product

  IT WAS REPORTED THAT PRODUCTS WERE FOUND TO BE NONCONFORMING DUE TO THE PRESENCE OF A FOREIGN SUBSTANCE. THE ISSUE WAS IDENTIFIED BY THE DISTRIBUTORSHIP DURING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364046 ↗
• MalfunctionOct 28, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DISTRIBUTOR IT WAS NOTED THAT THERE WAS A FOREIGN SUBSTANCE INSIDE THE STERILE PACKAGING. NO PATIENT INVOLVEMENT. DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403840 ↗
• InjuryAug 22, 2025Failure to Cut; Failure to Cut

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Graft failure

  MAUDE report 22872167 ↗
• MalfunctionAug 21, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO SURGERY ON (B)(6) 2025, THE STERILE PACKAGE WAS NOT SEALED. 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 22865384 ↗
• MalfunctionAug 1, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THERE WAS NO PRODUCT IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE VISUAL INSPECTION DETERMINED THERE IS NO SEAL ON THE RIGHT END OF THE PACKAGE. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22685664 ↗
• MalfunctionMar 27, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PRODUCT INSPECTION BY THE CUSTOMER, IT WAS FOUND THAT A PART OF THE STERILE PACKAGE IS NOT SEALED. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS 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 21713591 ↗
• MalfunctionFeb 26, 2025Incorrect Measurement; Incorrect Measurement

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21467981 ↗
• InjuryNov 12, 2024Activation Failure; Patient Device Interaction Problem; Activation Failure; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE 1.5:1 RATIO CARRIER CLEARLY MESHED THE SKIN GRAFT IN A 3:1 RATIO. THEY HAD TO TAKE ANOTHER GRAFT TO GET PROPER SIZE. THERE WAS NO SURGICAL DELAY REPORTED. THE SURGICAL TECHNIQUE FOR THE PRODUCT WAS UTILIZED. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20667969 ↗
• InjurySep 12, 2024Failure to Cut; Material Deformation; Patient Device Interaction Problem; Failure to Cut; Material Deformation; Patient Device Interaction Problem

  IT WAS REPORTED THAT DURING SURGERY, THE BLADE WAS BOWING. THE TAKEN GRAFT WAS DAMAGED AS IT WAS NOT ABLE TO TAKE IN ONE STRIP. SUTURES WERE NOT REQUIRED AT THE HARVEST SITE. THE PATIENT REQUIRED ADDITIONAL TIME UNDER ANESTHESIA AND ADDITIONAL SKIN GRAFTING WAS REQUIRED TO COMPLETE THE SURGERY. ANOTHER PRODUCT WAS NOT USED TO COMPLETE THE SURGERY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20207077 ↗
• MalfunctionApr 30, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING INCOMING INSPECTION, THE PRODUCT HAD A HAIR LIKE SUBSTANCE. THERE WAS NO HARM OR INJURY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19214577 ↗
• MalfunctionDec 18, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED. THEREFORE, THIS REPORT SHOULD BE VOIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18345041 ↗
• MalfunctionNov 28, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223218 ↗