DULEX 0115191Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741011849), received between May 21, 2019 and Dec 5, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Defective Device” (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. How this data works · Data updated Oct 13, 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.

• InjuryDec 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿ADHESIONS WERE LYSED. THERE WERE MULTIPLE HERNIA DEFECTS THAT WERE NOTED AND REDUCED. THE SMALL BOWEL DIVERTICULUM WAS NOTED AND RESECTED. THE HERNIA DEFECTS WITH OMENTUM WERE REDUCED. A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SUTURED.¿ (B)(6) 2006 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND ABDOMINAL MASS THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX KUGEL MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE SCAR WAS EXCISED. PURULENT MATERIAL WAS NOTED AND DRAINED. NECROTIC FAT WAS EXCISED. THE MESH WAS NOTED AND EXCISED ENTIRELY. THE DEFECT WAS IDENTIFIED AND REPAIRED WITH SYNTHETIC MESH.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH NON-HEALING WOUND THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF SCAR, DEBRIDEMENT OF FASCIA AND HERNIA REPAIRED WITH SUTURES. (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF DULEX MESH (DEVICE 2). PER OP NOTES, ¿LARGE SCAR WAS

  Patient problems: Hernia; Necrosis; Unspecified Infection

  MAUDE report 23727465 ↗
• InjurySep 4, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL DULEX ON (B)(6) 2008. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE DULEX. AS REPORTED, THE ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." ATTORNEY ALLEGES UNSPECIFIED INJURIES.

  Patient problems: Adhesion(s); Disability; Injury; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 8961675 ↗
• InjuryMay 21, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2016 OR (B)(6) 2017, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL DULEX (DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST (DEVICE #1) AND DULEX (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8629157 ↗