COMPOSIX 0134610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741031281), received between May 13, 2019 and Nov 5, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Defective Device” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

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

  PER INFORMATION PROVIDED: (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A RIGHT UPPER QUADRANT INCISION WAS MADE AND CARRIED DOWN TO THE FASCIA. HERNIA SAC WAS DISSECTED OUT. A LARGE COMPOSIX L/P MESH (DEVICE 1) WAS PLACED IN THE DEFECT AND TACKED WITH ABSORBABLE TACKERS. A VENTRIO MESH (DEVICE 2) WAS PLACED IN THE MIDLINE DESIGNED FOR THE MIDLINE INCISION AND TACKED WITH TACKERS.¿ (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INFECTED MESH WITH SMALL BOWEL FISTULA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF ALLOMAX MESH (DEVICE 3) AND EXPLANT OF COMPOSIX L/P MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE. SMALL BOWEL FISTULA WAS REMOVED. PREVIOUSLY PLACED INFECTED COMPOSIX L/P MESH (DEVICE 1) AND VENTRIO MESH (DEVICE 2) WERE REMOVED ENTIRELY. A ALLOMAX MESH (DEVICE 3) WAS PLACED IN THE DEFECT AND SECURE IT WITH SUTURES.¿

  Patient problems: Fistula; Unspecified Infection

  MAUDE report 23474568 ↗
• InjurySep 16, 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2007. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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: Adhesion(s); Hernia; Injury

  MAUDE report 10541941 ↗
• InjuryApr 2, 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX L/P. 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; Injury; Obstruction/Occlusion; Pain

  MAUDE report 9915619 ↗
• InjuryMay 13, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P (DEVICE #1 AND DEVICE #2) ON (B)(6) 2013. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL COMPOSIX L/P (DEVICE #1 AND DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 8603324 ↗