DULEX 0126341Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741011917), received between Nov 15, 2018 and Feb 26, 2026 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2003 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OPERATIVE NOTES, ¿OVER THE VENTRAL HERNIA IN THE MIDLINE, THE SAC WAS REDUCED AND COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SECURED IN PLACE WITH SUTURES CIRCUMFERENTIALLY ON BOTH SUPERIOR AND INFERIOR EDGES.¿ ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INFECTED ABDOMINAL WALL MESH (DEVICE 1) THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿IN THE MIDLINE, THE INFECTED OLD MESH (DEVICE 1) WAS DISSECTED FROM SURROUNDING TISSUES AND THEN EXCISED. AN OLD UNKNOWN MESH WAS EXPOSED, AND THIS WAS ALSO EXCISED. THE FASCIA WAS CLEARED AND SYNTHETIC MESH WAS PLACED OVER THE FASCIAL DEFECT AND DEFECT WAS REPAIRED CIRCUMFERENTIALLY WITH SUTURES.¿ (NOTE: THE MESH REMOVED DURING THIS PROCEDURE IS UNKNOWN). ON (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OPERATIVE NOTES, IN THE LOWER ABDOMEN, THE FISTULA EXTENDED WITH RECURRENCE OF THE PREVIOUSLY NOTED HERNIA. THE HERNIA DEFECT WAS REDUCED, AND A

  Patient problems: Abscess

  MAUDE report 24451774 ↗
• InjuryNov 15, 2018Defective Device; Defective Device

  BASED ON A REVIEW OF MEDICAL RECORDS: (B)(6) 2008 - THE PATIENT UNDERWENT AN EXTENSIVE LAPAROSCOPIC LYSIS OF ADHESIONS WITH EXTENSIVE VENTRAL ABDOMINAL WALL HERNIA REPAIR USING TWO DULEX MESH DEVICES (DULEX #1&2). ON (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH A NONHEALING FISTULA TRACT RIGHT LOWER QUADRANT. THE PATIENT UNDERWENT A DEBRIDEMENT OF SKIN AND SUBCUTANEOUS TISSUE AND MUSCLE. PER THE OP REPORT, "THERE WAS A PIECE OF MESH THERE, APPEARS TO BE GORE-TEX MESH (DULEX), IT WAS CONTIGUOUS SO HER INCISIONAL HERNIA REPAIR MESH SEEMS TO BE INFECTED." ON (B)(6) 2012 - THE PATIENT HAD AN INCISIONAL HERNIA REPAIR, PERFORMED LAPAROSCOPIC WITH TWO SEPARATE MESHES TACKED UP (DULEX #1&2), ONE TO THE RIGHT LOWER QUADRANT AND, IN FACT, IT HAS A CHRONICALLY DRAINING FISTULOUS TRACT AND ALSO CONTAMINATED, THE SECOND MESH IS IN THE MIDLINE. PER THE OP REPORT, THE PATIENT UNDERWENT AN "EXPLORATORY LAPAROTOMY, REMOVAL OF TWO INCISIONAL HERNIA MESHES (DULEX #1&2) ALONG WITH THE MULTITUDE OF TACKS AND THIS WAS FOLLOWED BY ABDOMINAL WALL DEBRIDEMENT, SKIN, SUBCUTANEOUS TISSUE, AND MUSCLE, AND THIS WAS FOLLOWED WITH CLOSURE OF INCISIONAL HERNIA MIDLINE PRIMARY." ALSO PER OP REPORT: "MIDLINE INCISI

  Patient problems: Adhesion(s); Fistula; Unspecified Infection

  MAUDE report 8074751 ↗