VENTRIO 0010218Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741016455), received between Jan 24, 2018 and Feb 23, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Defective Device” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Patient-Device Incompatibility

  PER ANSM USER REPORT (IN SUMMARY) (B)(4): DATE OF OCCURRENCE: (B)(6) 2024: PERIOD OF OCCURRENCE: IN THE WEEK FOLLOWING THE OPERATION. DESCRIPTION OF INCIDENT: LAPAROTOMY WITH PROSTHESES TWO PROSTHESES WERE INSTALLED: A 12 CM SYMBOTEX PROSTHESIS AND A 20 CM X 25 CM VENTRIO BARD PROSTHESIS WITH NON-ABSORBABLE STAPLES. SINCE THIS OPERATION, I HAVE HAD INTENSE PAIN IN MY STOMACH, FROM THE LOWER ABDOMEN TO THE TIPS THAT APPEAR AT THE NAVEL, SUBCUTANEOUS, MORPHINE SINCE 2024 AND FOLLOWED UP WITH 100 PAINKILLERS, AND IT'S USELESS. COMMENTS: THEY SHOULD HAVE TOLD ME BEFORE THE OPERATION THAT IT WOULD HURT EVEN MORE THAN BEFORE, AND THAT MY LIFE WOULD BE RUINED. I TRIED TO SEE OTHER SURGEONS AND THEY TOLD ME THAT I WOULD NEED ANOTHER OPERATION. SO, WHAT DOES THE FUTURE HOLD FOR ME AT 48 YEARS OLD?¿ PROCEDURE DATE: (B)(6) 2025. TITLE: DRAINAGE OF A PARIETAL HAEMATOMA LESIONS OBSERVED: PATIENT THREE WEEKS AFTER DOUBLE HERNIA REPAIR BY LAPAROTOMY WITH INTRAPERITONEAL PROSTHESES, INITIAL RECOVERY UNEVENTFUL; DURING A VIOLENT LIFTING EFFORT, FORMATION OF A LARGE, HYPERALGESIC PARIETAL HEMATOMA. CURRENT PATIENT STATUS: SINCE THE OPERATION, I HAVE BEEN ON MORPHINE AND AM BEING MONITORED BY A PAIN

  Patient problems: Abdominal Pain; Ambulation or Postural Difficulties; Fatigue; Hematoma

  MAUDE report 24413799 ↗
• InjuryMay 25, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ALLEGED PER CLINICAL TRIAL DVL-HE-020: ON (B)(6) 2013, THE PATIENT UNDERWENT MULTI-RECURRENT OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH (DEVICE #1) WAS PLACED. FASCIA AND FULL SKIN CLOSURE WAS ACHIEVED. (B)(6) 2015, PATIENT EXPERIENCED INCARCERATED RECURRENT INCISIONAL HERNIA. (B)(6) 2015 PATIENT ADMITTED TO THE HOSPITAL. THE RECURRENCE RESULTED IN REOPERATION. PATIENT UNDERWENT OPEN VENTRAL INCISIONAL HERNIA REPAIR, DURING WHICH A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED (DEVICE 2). AS REPORTED, NO ACTION WAS TAKEN RELATED TO THE PREVIOUSLY IMPLANTED MESH (DEVICE 1). THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. THE AE (RECURRENCE ¿ DEVICE 1) IS CLINICALLY ASSESSED TO BE SERIOUS AND POSSIBLY RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. (B)(6) 2019, A CULTURE WAS OBTAINED THE CULTURE TESTED POSITIVE FOR BACTERIAL INFECTION AS GORDONIA. (B)(6) 2020, PATIENT DEVELOPED CHRONIC NONHEALING ABDOMINAL WALL WITH SOFT TISSUE NECROSIS AND SEROMA (AE 2). THE REPORTED AE RESULTED IN REOPERATION AND PARTIALLY REMOVAL OF BOTH MESH. (B)(6) 2020, PATIENT UNDERWENT ADDITIONAL SURGICAL INTERVENTION, WHICH INCLUDED ADDITIONAL PAR

  Patient problems: Bacterial Infection; Hernia; Necrosis; Seroma

  MAUDE report 14497375 ↗
• InjuryMay 12, 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 VENTRIO PATCH ON (B)(6) 2020. 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

  MAUDE report 14369021 ↗
• InjuryDec 17, 2021Defective 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 VENTRIO ON (B)(6) 2018. 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: ON (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH LARGE VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRIO MESH. PER OPERATIVE NOTES, ¿THE PREVIOUSLY PLACED MESH WAS REMOVED. A LARGE PIECE OF VENTRIO MESH WAS PLACED INTO THE ABDOMEN AND TACKED.¿ (NOTE: THE PREVIOUSLY PLACED MESH WAS UNKNOWN MESH). ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH REMOVAL OF VENTRIO MESH. PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. A LARGE PIECE OF VENTRIO MESH WAS REMOVED. A SYNTHETIC MESH WAS PLACED AND SUTURED."

  Patient problems: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13024972 ↗
• InjuryMar 26, 2021Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2012. 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: Abscess; Adhesion(s); Fistula; Insufficient Information; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 11573395 ↗
• InjuryJan 29, 2021Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 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: Adhesion(s); Disability; Fistula; Injury; Pain; Purulent Discharge; Seroma; Unspecified Infection; Wound Dehiscence

  MAUDE report 11250372 ↗
• InjuryNov 11, 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 VENTRALIGHT ST ON (B)(6) 2011 AND/OR (B)(6) 2012. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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: Disability; Injury; Pain

  MAUDE report 10821278 ↗
• InjurySep 18, 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 MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRIO PATCH ON (B)(6) 2014 AND/OR (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2014 AND (B)(6) 2018. ATTORNEY ALSO 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); Hernia; Injury

  MAUDE report 10552607 ↗
• InjuryFeb 20, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN UMBILICAL HERNIA WITH A NON BARD/DAVOL PRODUCT ON OR ABOUT (B)(6) 2014. THE PATIENT UNDERWENT SURGICAL MESH REMOVAL AND REPAIR OF A RECURRENCE OF THE HERNIA DEFECT ON OR ABOUT (B)(6) 2014. DURING THIS PROCEDURE THE SURGEON NOTED THAT THE "SUPERIOR ASPECT OF THE MESH GRAFT WAS DETACHED FROM THE FASCIA" AND A VENTRIO PATCH WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON OR ABOUT (B)(6) 2015 THE PATIENT UNDERWENT SURGICAL MESH REMOVAL. DURING THE PROCEDURE, THE PREVIOUSLY PLACED MESH WAS INFECTED AND NOTED "COPIOUS AMOUNTS OF THIN PURULENT FLUID BETWEEN THE MESH AND THE PTFE." IT IS ALSO ALLEGED THAT THE PATIENT HAD BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY, DEPRESSION, DISABILITY, IMPAIRMENT AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Disability; Purulent Discharge; Unspecified Infection

  MAUDE report 9732633 ↗
• InjuryJan 6, 2020Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/ DAVOL VENTRIO PATCH ON (B)(6) 2013. 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); Fibrosis; Hernia; Inflammation; Injury

  MAUDE report 9553562 ↗
• InjuryJul 24, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ON (B)(6) 2014. 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: Abdominal Pain; Adhesion(s); Disability; Injury; Pain

  MAUDE report 8823312 ↗
• InjuryNov 21, 2018Defective Device; Material Deformation; Defective Device; Material Deformation

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2011: THE PATIENT UNDERWENT REPAIR OF AN INCISIONAL HERNIA. A BARD/DAVOL VENTRIO (DEVICE #1) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2016: THE PATIENT UNDERWENT SURGERY TO PARTIALLY EXPLANT THE INFECTED HERNIA MESH AND REPAIR A LARGE RECURRENT HERNIA. A BARD/DAVOL VENTRIO ST (DEVICE #2) WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. DURING THE SURGERY THE PHYSICIAN ENCOUNTERED A ¿LARGE RECURRENT VENTRAL HERNIA.¿ THE PHYSICIAN NOTED THAT ¿THERE WAS A SMALL BOWEL HERNIATED INTO THE HERNIA SAC AND THIS WAS ADHERED TO A BORDER OF MESH.¿ AND ¿THE BOWEL WAS TOO ADHERED TO THE MESH AND A SMALL ISLAND OF MESH WAS RESECTED AND LEFT WITH THE BOWEL. THE MESH HAD BUNCHED UP IN SEVERAL PLACES¿¿ THE PHYSICIAN REMOVED AS MUCH OF THE FAILED VENTRIO (DEVICE #1) AS HE COULD SAFELY REMOVE. ON (B)(6) 2017 TO (B)(6) 2047: THE PATIENT WAS ADMITTED TO THE HOSPITAL. DURING THIS EXTENDED HOSPITALIZATION, THE PATIENT UNDERWENT NUMEROUS SURGICAL PROCEDURES TO TREAT THE PATIENT'S CHRONIC ABDOMINAL INFECTIONS AND REMOVAL OF THE INFECTED VENTRIO ST (DEVICE #2). DURING THE VARIOUS PROCEDURES THAT WERE REQUIRED TO REMOVE THE INFECTED

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

  MAUDE report 8097278 ↗
• InjuryMar 9, 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) 2010: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL VENTRIO. ON (B)(6) 2014: THE PATIENT WAS INJURED. ON (B)(6) 2015: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF A BARD/DAVOL MODIFIED KUGEL HERNIA PATCH. AS REPORTED, THE 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: Abdominal Pain; Adhesion(s); Disability; Erosion; Pain

  MAUDE report 7328743 ↗
• InjuryJan 24, 2018Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2012: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A VENTRAL ABDOMINAL WALL HERNIA WITH MESH. A BARD/DAVOL VENTRIO HERNIA PATCH MESH, REFERENCE NUMBER 0010218, LOT NUMBER HUWE1791 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. ON (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO EXCISE INFECTED MESH WITH MATTED DENSE ADHESIVE DISEASE. AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE VENTRIO.

  Patient problems: Abscess; Adhesion(s); Disability; Obstruction/Occlusion; Scar Tissue; Unspecified Infection

  MAUDE report 7215627 ↗