COMPOSIX 0144680Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741031359), received between Oct 5, 2018 and Apr 21, 2026 — classified as 6 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P USING ECHO MESH (DEVICE 1). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. THE HERNIA DEFECT WAS NOTED AND REDUCED. A COMPOSIX L/P USING ECHO MESH (DEVICE 1) WAS PLACED AND TACKED CIRCUMFERENTIALLY USING SPIRAL TACKS.¿ ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, ¿OMENTAL ADHESIONS WERE TAKEN DOWN. THE PRIOR MESH (DEVICE 1) WAS NOTED TO BE JUST BELOW THE FASCIAL DEFECT. THE HERNIA DEFECT WAS REDUCED. A COMPOSIX L/P MESH (DEVICE 2) WAS PLACED AND TACKED CIRCUMFERENTIALLY.¿ ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND DIVERTICULOSIS THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH EXCISION OF COMPOSIX L/P USING ECHO MESH (DEVICE 1) AND COMPOSIX L/P (DEVICE 2). PER OP NOTES, ¿DENSE ADHESIONS BETWEEN OMENTUM AND PRIOR MESHES (DEVICE 1 AND 2) WERE LYSED. THERE WAS A RECURRENT HERNIA AND REDUCED. ALL THE PRIOR ABDOMINAL MESHES (DEVICE 1 AND 2) WERE EXCISED END REMOVED

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24939503 ↗
• InjurySep 5, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH WITH ECHO (DEVICE 1) AND COMPOSIX L/P MESH (DEVICE 2). PER OP NOTES, "A COMPOSIX L/P MESH WITH ECHO (DEVICE 1) AND COMPOSIX L/P MESH (DEVICE 2) WERE PLACED INTO THE ANTERIOR ABDOMINAL WALL USING TACKS." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH MULTIPLE RECURRENCE OF VENTRAL HERNIA AND EXTENSIVE LYSIS OF ADHESIONS THEREBY UNDERWENT REPAIR WITH REMOVAL OF OLD MESH (DEVICE 1 AND DEVICE 2). PER OP NOTES, "LYSIS OF ADHESIONS WAS PERFORMED. THE ENTIRE OLD MESHES (DEVICE 1 AND DEVICE 2) WERE REMOVED. DISSECTION WAS CARRIED TO THE DENSE SCAR TISSUE. A SYNTHETIC MESH WAS PLACED."

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

  MAUDE report 22975579 ↗
• InjuryNov 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) 2011. 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: Abdominal Pain; Adhesion(s); Erosion; Hernia; Injury

  MAUDE report 10806728 ↗
• MalfunctionApr 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED PER MEDWATCH FORM (B)(4): "WHEN USING THE MESH WITH THE ECHO POSITIONING SYSTEM, THE YELLOW PLASTIC ANCHOR FELL OFF OF THE BLUE TUBING INSIDE OF THE PATIENT (IT FELL OFF AFTER THE TUBING WAS CUT). THE SURGICAL TEAM SEARCHED THE ABDOMEN EXTENSIVELY WITH THE LAPAROSCOPE AND CHECKED THE TROCARS, INCLUDING CHECKING UNDER THE RUBBER GASKET OF THE 11MM OPTIVIEW TROCAR THAT WAS USED WITH THE MESH SYSTEM. RADIOLOGY WAS CALLED AND A FLAT PLATE WAS TAKEN OF A SECOND PIECE OF THE SAME MESH/POSITIONING SYSTEM. THE PIECE WAS NOT RADIOPAQUE AND DID NOT HAVE A MARKER, SO THE SURGEON OPTED NOT TO X-RAY THAT PATIENT'S ABDOMEN. THE SECOND PIECE WAS TAKEN BY THE SURGEON TO SHOW THE PATIENT'S FAMILY." THIS WAS A HERNIA REPAIR SURGERY. THE FOLLOWING WAS PROVIDED IN FOLLOW UP WITH THE HOSPITAL CONTACT: THE CASE WAS A LAPAROSCOPIC INCISIONAL REPAIR. THE INFLATION TUBE WAS GRASPED AT THE RETRIEVAL LOOP WITH A CARTER THOMASON GRASPER. THE INFLATION ASSEMBLY WAS USED SUCCESSFULLY TO PLACE THE MESH. AS REPORTED, THE YELLOW ANCHOR WAS NOT VISUALIZED DURING THE INFLATION PROCESS. AS THE SURGEON WAS REMOVING THE INFLATION ASSEMBLY "IT GOT STUCK IN A PORT AND AS THE SURGEON ATTEMPTED TO REMOVE IT THE

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9948776 ↗
• InjuryNov 8, 2019Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO (2) UNSPECIFIED BARD/DAVOL VENTRIO (DEVICE #1) AND (DEVICE #2) ON (B)(6) 2010 AND UNSPECIFIED BARD/DAVOL COMPOSIX L/P (DEVICE #3) ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) VENTRIO (DEVICE #1) AND (DEVICE #2) AND THE COMPOSIX L/P (DEVICE #3). 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."

  Patient problems: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9298228 ↗
• InjuryOct 18, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALIGHT ST(DEVICE #1). ON (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL COMPOSIX L/P(DEVICE #2). ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRALIGHT ST(DEVICE #3). ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRIO ST(DEVICE #4). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST(DEVICE #1), COMPOSIX L/P (DEVICE #2), VENTRALIGHT ST (DEVICE #3), AND VENTRIO ST (DEVICE #4). 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.

  Patient problems: Disability; Injury; Pain

  MAUDE report 7981487 ↗
• InjuryOct 5, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2012: THE PATIENT UNDERWENT REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL COMPOSIX L/P HERNIA MESH 6.2" X 6.8", LOT NUMBER HUVH1102 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2014: THE PATIENT UNDERWENT SURGERY DUE TO CHRONIC ABDOMINAL WALL PAIN. DURING THE SURGERY, THE SURGEON NOTED, "SEVERE INTRA-ABDOMINAL ADHESIONS, MESH INGROWTH INTO LIVER." THE COMPOSIX L/P IMPLANTED IN PLAINTIFF FAILED TO REASONABLY PERFORM AS INTENDED.THE PRODUCT CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY,NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PRODUCT HAD INITIALLY BEEN IMPLANTED TO TREAT. THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD/DAVOL COMPOSIX L/P. THE PATIENT WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE PRODUCT. THE BARD/DAVOL COMPOSIX L/P CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, NECESSITATING ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PRODUCT HAD INITIALLY BEEN IMPLANTED TO TREAT. IT IS ALLEGED THAT THE BARD/DAVOL COMPOSIX L/P IS DEFECTIVE. THE ATTORNEY ALLEGES THE PATI

  Patient problems: Adhesion(s); Disability; Hernia

  MAUDE report 7939570 ↗