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Versatex VTX1106Recalls & reported problems

Sofradim Production · Monofilament Mesh, Macroporous Polyester · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521532212), received between Apr 9, 2018 and Apr 9, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Degraded” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Degraded1
  • Product Quality Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 9, 2018Degraded; Product Quality Problem; Degraded; Product Quality Problem

    ACCORDING TO THE REPORTER, DURING A LEFT OPEN INGUINAL HERNIA REPAIR, WHILE BEING APPLIED INTO THE GROIN THE MESH WAS DAMAGED. WHILE THE SURGEON WAS CUTTING OF THE MESH THE SURGEON SAW THE MESH UNRAVEL AT THE CUT EDGES AND FURTHER REINFORCEMENT WAS REQUIRED. OPERATIVE APPROACH WAS TO PLUG AND PATCH. THE SIZE OF THE DEFECT WAS 2.5 CM. THE APPEARANCE OF THE MESH WAS NORMAL BEFORE USE, BUT AFTER USE, THE MESH WAS FRAYING BADLY. TO RESOLVE THE ISSUE, ANOTHER PIECE OF MESH WAS USED WHICH RESULTED IN THE PATIENT HAVING THREE (3) MESH PIECES IMPLANTED. THE FIXATION USED WAS SUTURES. NO PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7409950 ↗

Other Mesh, Surgical, Polymeric devices

All Mesh, Surgical, Polymeric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.