DULEX 0110151Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741011795), received between Aug 11, 2020 and Feb 18, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Defective Device” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF BARD DULEX MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A BARD DULEX MESH (DEVICE 1) WAS PLACED AND SUTURED¿. ON (B)(6) 2012- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE RIGHT LOWER QUADRANT WHICH WAS ABOVE THE PREVIOUSLY PLACED MESH (DEVICE 1). A VENTRALIGHT ST MESH (DEVICE 2) WAS CUT AND PLACED IN THE DEFECT REGION AND SUTURED¿. ON (B)(6) 2013- PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF BARD DULEX MESH (DEVICE 1), VENTRALIGHT ST MESH (DEVICE 2), IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, ¿THE RECURRENT HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS REDUCED. A VENTRALIGHT ST MESH (DEVICE 3) WAS PLACED AND SUTURED¿.

  Patient problems: Hernia

  MAUDE report 24380814 ↗
• InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF DULEX MESH (DEVICE #1). PER OP NOTES, ¿A DULEX MESH (DEVICE #1) WAS ORIENTED IN AN OBLIQUE FASHION AND SUTURED CIRCUMFERENTIALLY.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #2). PER OP NOTES, ¿THE PREVIOUSLY PLACED MESH (DEVICE #1) WAS REPERITONEALIZED AND DISSECTED THE ADHESIONS. A COMPOSIX L/P MESH (DEVICE #2) WAS PLACED INTO THE DEFECT AND TACKED USING SORBAFIX FIXATION DEVICE.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22552992 ↗
• InjuryMay 14, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF TWO COMPOSIX L/P (DEVICE # 1 & # 2). PER OP NOTES, ¿TWO COMPOSIX L/P MESH (DEVICE #1 & #2) WERE PLACED WITHIN THE ABDOMEN AND TACKED TO THE LEFT ASPECT OF THE HERNIA USING SUTURES.¿ (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE # 3). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. A DULEX MESH (DEVICE # 3) WAS PLACED IN THE ABDOMEN AND TACKED TO THE OVERLYING PERITONEUM USING SUTURES.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED COMPOSIX L/P (DEVICE #1 & #2) DURING THIS REPAIR). (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #4). PER OP NOTES, ¿A SMALL DEFECT WAS NOTED IN THE LEFT LOWER QUADRANT WHERE TWO PREVIOUS PLACED MESHES (DEVICE # 1 & # 2) COME TOGETHER. A VENTRALEX MESH (DEVICE #4) WAS PLACED IN THE ABDOMEN AND TACKED OVER TO OVERLIE THE DEFECT.¿ (NOTE: THERE IS NO MENTION/VISUALIZATION OF PREVIOUSLY PLACED DULEX M

  Patient problems: Abscess; Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 22021480 ↗
• InjuryMar 5, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH COMPLEX RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD DULEX MESH . PER OPERATIVE NOTES, "THE HERNIA SAC WAS DISSECTED FREE FROM THE FEMORAL CANAL INTO THE GROIN AREA, THE PREVIOUSLY PLACED UNKNOWN MESH WAS DISLODGED FROM THE HERNIA SAC. THE PREVIOUS UNKNOWN MESH WAS EXCISED FROM IT'S INFLAMMATORY MASS IN THE INGUINAL CANAL. THE HERNIA DEFECT WAS CLOSED AND REDUCED. A BARD DULEX MESH (DEVICE #1) WAS PLACED MEDIAL TO THE PUBIC TUBERCLE ALONG THE INGUINAL LIGAMENT AND SUTURED." (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH BILATERAL SYMPTOMATIC RECURRENT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED TRANSABDOMINAL LAPAROSCOPIC PREPERITONEAL BILATERAL INGUINAL HERNIA REPAIR WITH IMPLANT OF 3DMAX LIGHT MESHES (DEVICE #2 & #3). PER OPERATIVE NOTES, "THE BILATERAL INGUINAL HERNIA WAS NOTED, THE PREPERITONEAL MESH (DEVICE #1) WAS SEEN. THE MESH WAS ADHERENT TO THE PERITONEUM. THE LARGE HERNIA SAC WAS REDUCED ON THE LEFT SIDE. THE SAME PROCESS WAS DONE ON RIGHT SIDE. A 3DMAX LIGHT MESH (DEVICE #2) SUTURED TO COOPER LIGAMENT IN INTERRUPTED FASHION ON LEFT SIDE, SIMILAR REPAIR WAS DONE O

  Patient problems: Adhesion(s); Hernia; Pain; Scar Tissue

  MAUDE report 21523608 ↗
• InjurySep 27, 2021Defective Device; Material Deformation; Patient Device Interaction Problem; Migration; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Hernia; Insufficient Information; Unspecified Infection

  MAUDE report 12531418 ↗
• InjuryAug 11, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST AND BARD GRAFT DULEX ON (B)(6) 2009 AND/OR (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD GRAFT DULEX. 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." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Hernia; Injury; Pain

  MAUDE report 10389364 ↗