VENTRIO 0010219Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741016462), received between Dec 29, 2017 and Feb 2, 2021 — classified as 9 injuries.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2021Defective 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 UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2013 AND (B)(6) 2014. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT'S BOWEL OBSTRUCTION WAS DIAGNOSED IN 2019. 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; Hernia; Obstruction/Occlusion; Pain; Scar Tissue

  MAUDE report 11267566 ↗
• InjuryJul 17, 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 UNSPECIFIED BARD/DAVOL VENTRIO AND SOFT MESH ON (B)(6) 2011 AND/OR (B)(6) 2014. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED VENTRAL INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE #1). PER OP NOTES, ¿THE ENTIRE SKIN SCAR WAS EXCISED. MULTIPLE VENTRAL HERNIA DEFECTS WERE IDENTIFIED WITH INCARCERATED OMENTUM. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED TO REMOVE OMENTUM. THE HERNIA SAC WAS EXCISED. A VENTRIO MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRIO MESH (DEVICE #

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

  MAUDE report 10288469 ↗
• InjuryMar 6, 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 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 ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Disability; Injury; Pain; Unspecified Infection

  MAUDE report 9797731 ↗
• InjuryNov 8, 2019Failure to Unfold or Unwrap; Defective Device; Insufficient Device Problem Information; Failure to Unfold or Unwrap; Defective Device; Insufficient Device Problem Information

  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: Disability; Injury; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 9298225 ↗
• InjuryJul 8, 2019Defective Component; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Component; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR 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. 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; Injury; Obstruction/Occlusion; Pain; Seroma

  MAUDE report 8769227 ↗
• InjurySep 17, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2015: THE PATIENT UNDERWENT REPAIR OF A VENTRAL ABDOMINAL HERNIA. A BARD/DAVOL VENTRIO WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT WAS EXPERIENCING EXTREME ABDOMINAL PAIN AND HAD TO UNDERGO SURGICAL INTERVENTION TO REMOVE THE DEFECTIVE MESH, ALONG WITH ADHESIONS TAKEN DOWN ALONG BOTH SIDES OF THE MESH. THE ATTORNEY ALLEGES THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE BARD MESH AND MAY REQUIRE ADDITIONAL SURGERIES. THE PRODUCT IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. IT CAUSED SERIOUS INJURY AND HAD TO BE REVISED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE PRODUCT WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT WAS CAUSED TO SUFFER SEVERE PERSONAL INJURIES, PAIN AND SUFFERING. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY AND IMPAIRMENT.

  Patient problems: Adhesion(s); Disability; Injury

  MAUDE report 7883436 ↗
• InjurySep 17, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2001: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL VENTRAL HERNIA. A BARD/DAVOL VENTRIO MESH PATCH 16 X 31 CM, LOT NO. HUUB0023 WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR ON (B)(6) 2017: THE PATIENT UNDERWENT REMOVAL OF THE FAILED BARD/DAVOL VENTRIO MESH. DURING THE PROCEDURE, THE SURGEON HAD TO RESECT A PORTION OF THE PATIENT'S BOWEL IN ORDER TO RELEASE THE FAILED BARD/DAVOL VENTRIO MESH. THE ATTORNEY ALLEGES THAT THE BARD/DAVOL VENTRIO MESH IS DEFECTIVE. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, AND IMPAIRMENT.

  Patient problems: Adhesion(s); Disability; Fibrosis; Fistula; Injury; Pain; Unspecified Infection

  MAUDE report 7880359 ↗
• InjuryJun 5, 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: ON (B)(6) 2015 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. NI/NI/NI - THE PATIENT HAD UNSPECIFIED INJURIES INCLUDING CONSULTATIONS WITH HER MEDICAL PROVIDERS. AS ALLEGED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO. AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED."

  Patient problems: Disability; Hernia; Injury; Necrosis; Pain; Unspecified Infection

  MAUDE report 7571610 ↗
• InjuryDec 29, 2017Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2013 - THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INCISIONAL VENTRAL HERNIA, A VENTRIO HERNIA MESH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2013 - THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE INFECTED MESH. THE ATTORNEY ALLEGES THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PAIN AND WAS INJURED SEVERELY AND PERMANENTLY.

  Patient problems: Adhesion(s); Cellulitis; Disability; Pain; Unspecified Infection

  MAUDE report 7153869 ↗