COMPOSIX 0134113Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741031243), received between Sep 26, 2019 and Jun 30, 2026 — 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. How this data works · Data updated Oct 13, 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 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 1). PER OPERATIVE NOTES, "AN INCISION WAS MADE INTO THE UPPER MIDLINE. THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED IT WITH SUTURES." ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH ADHESION, RECURRENT VENTRAL INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OPERATIVE NOTES, "A MIDLINE INCISION WAS MADE INTO THE ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. THERE WERE DENSE ADHESIONS PRESENT INTO THE ABDOMEN. ALL ADHESIONS WERE TAKEN DOWN SHARPLY. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED INTO THE ANTERIOR ABDOMINAL WALL AND SECURED IT WITH SUTURES." ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REINFORCEMENT OF EXISTING MESH. PER OPERATIVE NOTES, "MULTIPLE LOOPS OF SMALL BOWEL WERE ADHERENT TO THE EPIGASTRIC AREA. ALL ADHESIONS WERE TAKEN DOWN SHARPLY. THE PREVIOUS DEFECT ITSELF HAD BEEN ADEQUATELY COVERED AND REINFORCED WITH PREVIOUSLY P

  Patient problems: Adhesion(s); Hernia

  MAUDE report 25666782 ↗
• InjuryMar 27, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS. ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX L/P (DEVICE #1). PER OPERATIVE NOTES, ¿THE PATIENT HAD VERY DENSE INTRAABDOMINAL ADHESIONS DENSELY ADHERING HIS SMALL AND LARGE INTESTINE TO THE ANTERIOR ABDOMINAL WALL. A COMPOSIX L/P MESH (DEVICE #1) WAS THEN PLACED TO THE ANTERIOR ABDOMINAL WALL WITH A TACKING DEVICE USING SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA & CHRONIC RIGHT LOWER QUADRANT ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿UPON ENTERING THE ABDOMINAL CAVITY, THE PATIENT HAD VERY DENSE ADHESIONS ADHERING THE SMALL BOWEL AND COLON TO THE ANTERIOR ABDOMINAL WALL. THE OLD MESH (DEVICE #1) WAS OPENED IN THE MIDLINE, AND IT WAS GRASPED ON BOTH SIDES WITH KOCHER CLAMPS AND USING BLUNT AND SHARP DISSECTION THE SMALL BOWEL AND COLON WERE REMOVED FROM THE ANTERIOR ABDOMINAL WALL. A VENTRIO ST MESH (DEVICE #2) WAS PLACED TO THE ANTERIOR ABDOMINAL WALL USING TACKS.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INC

  Patient problems: Abdominal Pain; Adhesion(s); Erosion; Fistula; Hernia; Inflammation; Unspecified Infection

  MAUDE report 21707061 ↗
• InjuryMar 14, 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 AN UNSPECIFIED BARD/DAVOL COMPOSIX L/P ON (B)(6) 2008. 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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13759377 ↗
• InjuryDec 9, 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) 2009. 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; Pain

  MAUDE report 10976055 ↗
• InjuryOct 8, 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) 2010. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST COMPOSIX L/P. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH RECURRENT SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO COMPOSIX L/P MESH (DEVICE #1 & #2). PER OP NOTES, "THE COMPOSIX L/P MESH (DEVICE #1 & #2) WERE PLACED AND SUTURED." (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE #3). PER OP NOTES, "A COMPOSIX L/P MESH (DEVICE #3) WAS PLACED, SUTURED AND TACKED." (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF COMPOSIX L/P MESHES (DEVICE #1, #2 & #3) AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "TWO PIECES OF OLD MESH (DEVICE #1 & #2) WERE REMOVED. A LARGE MESH (

  Patient problems: Abdominal Pain; Injury

  MAUDE report 10649647 ↗
• InjurySep 26, 2019Defective 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 BARD MESH (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL COMPOSIX E/X (DEVICE #2) ON (B)(6) 2003 OR (B)(6) 2011. 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 BARD MESH (DEVICE #1) AND THE COMPOSIX E/X (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 9126470 ↗