DULEX 0126342Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741011924), received between Mar 26, 2025 and Mar 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

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

• InjuryMar 26, 2025Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2001 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED, AND A COMPOSIX MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE #2). PER OPERATIVE NOTES, ¿LYSIS OF ADHESIONS WAS PERFORMED. A DUAL MESH (DEVICE #2) WAS PLACED AND TACKED." (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX MESH (DEVICE #1) AND IMPLANT OF BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) WAS FOUND DISRUPTED FROM THE ANTERIOR ABDOMINAL WALL WAS EXCISED COMPLETELY AND REMOVED. THE MESH (DEVICE #2) ON THE RIGHT SIDE WAS FOUND IN GOOD POSITION. A BIOLOGICAL MESH WAS PLACED AND SUTURED." (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF DULEX MESH (DEVICE #2) AND BIOLOGICAL MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS REDUCED. LYSIS OF ADHESIONS WAS PE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 21696076 ↗