MeshgraftTM II Tissue Expansion System 00-2195-014-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00889024372573), received between Jun 15, 2023 and Oct 28, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 28, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20547254 ↗
• InjuryOct 28, 2024Failure to Cut; Patient Device Interaction Problem; Failure to Cut; Patient Device Interaction Problem

  THERE IS NO ADDITIONAL INFORMATION REGARDING THE EVENT.

  Patient problems: Laceration(s); Skin Tears

  MAUDE report 20546751 ↗
• MalfunctionJun 15, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  IT WAS REPORTED BY INCOMING INSPECTION OF THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO HAVE DEBRIS IN THE STERILE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. AT PRODUCT EVALUATION INVESTIGATION THE FOREIGN MATERIAL WAS FOUND TO BE GREATER THAN 0.60 SQ. MM IN SIZE THE PIECE IS CONSIDERED NONCONFORMING. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133694 ↗