VENTRIO 0010216Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741016431), received between Mar 15, 2018 and Oct 20, 2022 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO PATCH. 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; Insufficient Information; Scar Tissue

  MAUDE report 15637298 ↗
• MalfunctionOct 15, 2021Contamination of Device Ingredient or Reagent; Device Contamination with Chemical or Other Material; Contamination of Device Ingredient or Reagent; Device Contamination with Chemical or Other Material

  AS REPORTED, UPON OPENING THE PACKAGE OF THE BARD/DAVOL VENTRIO MESH DURING A PROCEDURE ON (B)(6) 2021, A "WHITE FOREIGN MATERIAL" WAS NOTED WITHIN THE INNER PACKAGE. AS REPORTED, NO DAMAGE WAS NOTED ON THE OUTER PACKAGE AND THE MESH WAS IMPLANTED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12638717 ↗
• InjurySep 7, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2009, A NON-BARD/DAVOL MESH WAS IMPLANTED IN THE PATIENT'S ABDOMEN TO REPAIR AN INCISIONAL HERNIA. THE PATIENT UNDERWENT REPAIR OF A RECURRENT HERNIA ON OR ABOUT (B)(6) 2013. A BARD/DAVOL VENTRIO MESH PATCH WAS IMPLANTED DURING THIS REPAIR. THE PATIENT UNDERWENT REMOVAL OF THE MESH PRODUCTS ON OR ABOUT (B)(6) 2013. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN, INFLAMMATION, ADHESIONS, BOWEL OBSTRUCTION, RECURRENCE, SURGERY TO REMOVE MESH, INFECTION, FISTULA, ABDOMINAL WALL RECONSTRUCTION, AND OPEN DRAINING WOUND, WHICH HAVE IMPAIRED THE PATIENT'S ACTIVITIES OF DAILY LIVING AND CONTINUES TO SUFFER COMPLICATIONS AS A RESULT OF BEING IMPLANTED WITH THE MESH PRODUCTS. THE VENTRIO MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE VENTRIO MESH WAS INITIALLY IMPLANTED TO TREAT. THE ATTORNEY ALLEGES PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES, PERMANENT IMPAIRMENT, MENTAL PAIN AND SUFFERING SUSTAINED BY THE PAT

  Patient problems: Disability; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 10499171 ↗
• InjuryJun 5, 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 THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH ON (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO PATCH. IT IS ALLEGED 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; Obstruction/Occlusion

  MAUDE report 10122018 ↗
• InjuryApr 23, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON OR ABOUT (B)(6) 2017. 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); Disability; Injury; Obstruction/Occlusion; Pain

  MAUDE report 9989794 ↗
• InjuryMar 26, 2020Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR THE IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. 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); Disability; Fibrosis; Hernia; Injury; Pain; Seroma; Unspecified Infection

  MAUDE report 9882304 ↗
• InjuryFeb 28, 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 VENTRIO PATCH ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO PATCH. 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); Injury; Unspecified Infection

  MAUDE report 9768856 ↗
• InjuryDec 6, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2016: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A VENTRIO MESH PATCH 22.1CM X 27.1CM, REFERENCE NUMBER 0010216, LOT NUMBER HUZK0155 WAS IMPLANTED IN PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT A PROCEDURE FOR IRRIGATION AND DEBRIDEMENT OF AN ABDOMINAL WALL SEROMA. ON (B)(6) 2016: THE PATIENT UNDERWENT A PROCEDURE FOR IRRIGATION AND DEBRIDEMENT OF PATIENT'S NON-HEALING ABDOMINAL WOUND. ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE INFECTED INCISIONAL HERNIA MESH. ON (B)(6) 2017: THE PATIENT UNDERWENT A PROCEDURE FOR IRRIGATION AND DEBRIDEMENT OF PATIENT¿S NON-HEALING ABDOMINAL WOUND. AS ALLEGED, THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT.

  Patient problems: Disability; Seroma; Unspecified Infection

  MAUDE report 8139586 ↗
• InjuryNov 27, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2014: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. NI/NI/NI: THE PATIENT HAD UNSPECIFIED INJURIES. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. THE PATIENT'S 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); Ascites; Bowel Perforation; Disability; Erosion; Hernia; Injury; Pain; Unspecified Infection

  MAUDE report 8108259 ↗
• InjuryMar 15, 2018Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2017: THE PATIENT UNDERWENT REPAIR OF INCARCERATED INCISIONAL HERNIA. A BARD/DAVOL EXTRA LARGE OVAL VENTRIO MESH PATCH, 8.7IN X 10.7IN, (B)(4), LOT NUMBER HUYK0114 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2017: THE PATIENT UNDERWENT SURGERY TO EXPLANT AN INFECTED INCISIONAL HERNIA MESH. AS REPORTED BY THE PATIENT'S ATTORNEY, DURING THE SURGERY, THE SURGEON MADE THE FOLLOWING FINDINGS: "[P]ATIENT HAS EVIDENCE OF MESH INFECTION. I MAKE A MIDLINE INCISION OVER THE PREVIOUS SKIN OPENING. IMMEDIATELY IS A DISSECT THROUGH THE SUBCUTANEOUS TISSUE EXPOSED MESH IS IDENTIFIED. AS I EXTEND THE INCISION I REALIZE THAT THE CENTRAL PORTION OF THE MESH WAS NOT INCORPORATED WELL AND IS UNFORTUNATELY EXPOSED AND THEREFORE CONTAMINATED. A FULL-THICKNESS DEBRIDEMENT WILL BE NEEDED. UNFORTUNATELY THE ENTIRE 90%OF THE MESH IS WELL INCORPORATED BUT NOW HAS TO BE REMOVED. I BEGAN THE TEDIOUS PROCESS OF MESH EXPLANT. THE MIDLINE MESH IS CUT IN HALF. THIS ALLOWS ME TO GRASP THE MESH AND STRIP IT FREE OF THE ABDOMINAL WALL. THIS PORTION OF THE PROCEDURE WAS MARKED WITH EXTREME DIFFICULTY DUE TO THE WELL INCORPORATED MESH IN THE SURRO

  Patient problems: Abscess; Adhesion(s); Disability; Foreign Body Reaction; Granuloma; Inflammation; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 7342879 ↗