COMPOSIX 0134790Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741031304), received between Jul 21, 2020 and Jun 7, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Defective Device” (5 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.

• InjuryJun 7, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA (X2) THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX L/P MESH (DEVICE #1, #2). PER OPERATIVE NOTES, "TWO DISCRETE HERNIAS, ONE IN LEFT LOWER QUADRANT AT SITE OF OLD COLOSTOMY SITE AND ONE IN UMBILICUS. LEFT LOWER QUADRANT WAS REPAIRED USING A COMPOSIX L/P MESH (DEVICE #1) AND TACKED. VENTRAL ANTERIOR UMBILICAL HERNIA WAS REPAIRED USING COMPOSIX L/P MESH (DEVICE #2) AND TACKED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL INCISIONAL HERNIAS WITH INCARCERATION THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF SYNTHETIC MESHES AND REMOVAL OF MESH (DEVICE #1, #2). PER OPERATIVE NOTES, "PIECES OF DISRUPTED MESH ALONG THE ANTERIOR ABDOMINAL WALL WAS ADHERENT TO LOOPS OF BOWEL AND WERE REMOVED. TWO SYNTHETIC MESHES WERE PLACED AND SUTURED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22163697 ↗
• InjuryFeb 18, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX E/X MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. A COMPOSIX OVAL MESH (DEVICE #1) WAS THEN PLACED INTO THE ABDOMINAL CAVITY AND SECURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH LARGE INCISIONAL HERNIA WITH CONTAMINATED MESH AND ADHESIONS THEREBY UNDERWENT REPAIR WITH IMPLANT OF PHASIX ST MESH (DEVICE #2) AND REMOVAL OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE MESH (DEVICE #1) AND IDENTIFIED AND DISSECTED FROM SURROUNDING AREA WHICH REVEALED ADHESIONS. A PHASIX ST MESH (DEVICE #2) WAS PLACED INTRAABDOMINALLY AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT LARGE INCISIONAL ABDOMINAL WALL HERNIA AND ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE #3) AND COMPOSIX L/P MESH (DEVICE #4) AND LYSIS OF ADHESIONS. PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED ONLAY PATCH (DEVICE #2) WAS NOTED TO BE INTACT AND THERE WERE ADHESIONS TO THE ANTERIOR ABDOMINAL CAVITY. A COMPOSIX MESHES (DEVICE #3 & #4) WAS PLACED IN THE AREA OF ABDOMINAL CAVITY AND SECU

  Patient problems: Abscess; Bacterial Infection; Scar Tissue

  MAUDE report 21400359 ↗
• InjuryJul 19, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL COMPOSITE MESHES (COMPOSIX MESH) ON (B)(6) 2012 AND (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. 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: Adhesion(s); Insufficient Information; Pain

  MAUDE report 15061450 ↗
• InjuryJun 28, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX AND COMPOSIX LP ON (B)(6) 2011 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2013 AND (B)(6) 2020 DUE TO THE HERNIA MESH DEVICE. 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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 14841074 ↗
• InjurySep 12, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL COMPOSIX L/P MESH IN THE COURSE OF AN INCISIONAL HERNIA REPAIR SURGERY ON (B)(6) 2013. IT IS ALLEGED THAT FURTHER TO THE IMPLANTATION WITH THE PRODUCT, THE PATIENT SUFFERED MESH INFECTION. ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT A CORRECTIVE REVISION SURGERY ON (B)(6) 2013 AND ANOTHER CORRECTIVE REVISION SURGERY ON (B)(6) 2017. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED INJURIES, LOSSES, AND DAMAGES RESULTING FROM NUMEROUS DEFECTS IN THE PRODUCT THAT CREATE AN UNREASONABLY HIGH RISK OF INJURY WITH SEVERE PERMANENT ADVERSE HEALTH CONSEQUENCES. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED INJURIES INCLUDING INFECTION, ADHESION, WOUND DEHISCENCE, EVISCERATION, HERNIA RECURRENCE, PERMANENT INJURIES INCLUDING SCARRING, DISFIGUREMENT, SUFFERING AND PHYSICAL DISABILITY. IT IS ALLEGED THAT THE PATIENT CONTINUES TO UNDERGO MEDICAL CARE AND TREATMENT. IT IS ALSO ALLEGED THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Unspecified Infection; Wound Dehiscence

  MAUDE report 12457829 ↗
• InjuryJul 21, 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 LP ON (B)(6) 2009. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE COMPOSIX LP. 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: Abscess; Adhesion(s); Disability; Fistula; Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 10300853 ↗