Versatex VTX1515MX3Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521532649), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 death.

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

Recent adverse event reports

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

• DeathMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, IT WAS NOTED THE PATIENT HAD PREVIOUSLY UNDERGONE COLECTOMY AND ILEUS OPERATION TWICE BY SURGERY FOR INTESTINAL PERFORATION DONE BY ILEOSTOMY. WHEN CLOSING THE ABDOMINAL WALL AFTER VACUUM-ASSISTED CLOSURE (VAC) AND ALSO 4 DAYS AFTER THERE WAS IATROGENIC INTESTINAL PERFORATION WITH DIFFUSE PERITONITIS, STOMI, THE MONOFILAMENT MESH FOR REINFORCEMENT OF THE FASCIA WAS APPLIED AND SUTURE WAS USED. THERE WAS CHRONIC WOUND INFECTION THAT REAPPEARED, WHICH DESPITE REPEATED ANTIBIOTIC CURES, VAC AND MORE REOPERATIONS DID NOT REHABILITATE. THE PATIENT WAS INCREASINGLY WEAKENED AND MEDICAL COMPLICATIONS INCLUDED DEATH.

  Patient problems: Bowel Perforation; Muscle Weakness/Atrophy; Necrosis; Peritonitis; Post Operative Wound Infection; Unspecified Tissue Injury

  MAUDE report 13757432 ↗