VENTRIO 0010217Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741016448), received between Nov 20, 2018 and Oct 23, 2025 — classified as 7 injuries, 1 malfunction.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS UNDERWENT FOR INCISIONAL HERNIA REPAIR WITH IMPLANT OF VENTRAL MESH (DEVICE 1), REDUCTION OF INCARCERATED OMENTAL TISSUE, TAKES DOWN OF FALCIFORM LIGAMENT. (PPF) (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA AND THEREBY UNDERWENT IMPLANT WITH VENTRALIGHT MESH (DEVICE 2). (PPF). PER REVIEW OF MEDICAL RECORD: (B)(6) 2011 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO MESH (DEVICE 1). PER OP NOTES, ¿A VENTRIO MESH (DEVICE 1) WAS PLACED INTO ANTERIOR ABDOMINAL WALL USING SORBAFIX TACKS.¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE 2). PER OP NOTES, ¿ADHESIONS FROM PREVIOUS REPAIR WAS LYSED. A HERNIA WAS IDENTIFIED AT UMBILICUS. A VENTRALIGHT ST USING ECHO PS (DEVICE 2) WAS PLACED INTO ABDOMINAL WALL AND TACKED.¿

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 23366566 ↗
• MalfunctionMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: (B)(6) 2017 SUBJECT PATIENT UNDERWENT PRIMARY OPEN VENTRAL LEFT SUBCOSTAL HERNIA REPAIR. THE SIZE OF THE HERNIA DEFECT WAS 26 CM X 10 CM. A BARD/DAVOL VENTRIO HERNIA PATCH WAS PLACED IN AN UNDERLAY FASHION FIXATED USING MECHANICAL FIXATION DEVICE AND SUTURE. FASCIA CLOSURE WAS COMPLETED USING MECHANICAL SUTURE AND FULL SKIN CLOSURE WAS ACHIEVED USING STAPLES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2017. (B)(6) 2017 SUBJECT PATIENT WAS DIAGNOSED WITH SEROMA. THIS AE IS CLINICALLY ASSESSED TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THIS HAS BEEN ASSESSED AS A NON-SERIOUS ADVERSE EVENT OF MILD SEVERITY AND HAS RESOLVED. NO ACTION TAKEN. THE REPORTED ADVERSE EVENTS DOES NOT MEET THE DEFINITION OF AN SAE (SERIOUS ADVERSE EVENT).

  Patient problems: Seroma

  MAUDE report 14457271 ↗
• InjuryJun 9, 2021Material Separation; Patient-Device Incompatibility; Material Separation; Patient-Device Incompatibility

  ON (B)(6) 2011- THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR WITH IMPLANT OF A BARD/DAVOL X-LARGE VENTRIO MESH. IN (B)(6) 2021 - THE PATIENT RETURNED TWO WEEKS BEFORE (B)(6) 2021 WITH AN ABDOMINAL ABSCESS. ON (B)(6) 2021 - THE SURGEON PERFORMED AN EXPLORATORY LAPAROTOMY AND DISCOVERED THAT THE MESH HAD SEPARATED FROM THE LAYERS. AS REPORTED, "THE SURGEON STATED THAT THE MESH HAD STARTED SEPARATING AND HE THINKS THIS CAUSED AN INFECTION." AS REPORTED, THE SURGEON FELT THAT MESH WAS POSSIBLY DEFECTIVE AND SHOULD NOT HAVE SEPARATED. THE REMNANT OF THE MESH WAS SENT TO PATHOLOGY. AS REPORTED, THE PATIENT IS DOING WELL AND WAS DISCHARGED TO HOME.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 11966894 ↗
• InjuryJun 4, 2020Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH ON (B)(6) 2016. 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: Abscess; Adhesion(s); Fistula; Injury; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 10118447 ↗
• InjuryMay 22, 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 VENTRIO ON (B)(6) 2010. IT IS ALSO ALLEGED BY PATIENT ATTORNEY THAT ON (B)(6) 2017, THE PATIENT HAD UNSPECIFIED INJURIES. 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: Disability; Injury; Necrosis; Pain; Unspecified Infection

  MAUDE report 8634073 ↗
• InjuryJan 29, 2019Defective 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) 2016: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO PATCH. THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO PATCH. THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Abscess; Adhesion(s); Injury; Obstruction/Occlusion; Purulent Discharge; Seroma; Unspecified Infection

  MAUDE report 8287143 ↗
• InjuryJan 4, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Material Deformation; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2011: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO. 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: Abdominal Pain; Adhesion(s); Disability; Drug Resistant Bacterial Infection; Fistula; Inflammation; Injury; Pain

  MAUDE report 8219010 ↗
• InjuryNov 20, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2010: THE PATIENT UNDERWENT REPAIR OF A VENTRAL HERNIA. A BARD/DAVOL VENTRIO WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. ON (B)(6) 2017: THE PATIENT UNDERWENT SURGERY TO EXPLANT THE INFECTED VENTRIO MESH. DURING THE SURGERY THE PHYSICIAN NOTED THAT "THE MESH APPEARED TO BE INVOLVED WITH AN INFECTED ABSCESS WITHIN THE ABDOMEN." ON (B)(6) 2017: THE PATIENT UNDERWENT A REPAIR OF AN INTESTINAL FISTULA SECONDARY TO THE MESH INFECTION. THE PHYSICIAN NOTED THAT THE PATIENT WOULD REQUIRE ADDITIONAL SURGERY TO IMPLANT ANOTHER MESH DEVICE. THE PATIENT CONTINUES TO EXPERIENCE COMPLICATIONS RELATED TO THE MESH AND WILL LIKELY REQUIRE ADDITIONAL SURGERIES TO REPAIR THE DAMAGE FROM THE MESH. THE MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE MESH CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE AND PERMANENT PAIN, SUFFERING, ANXIETY DEPRESSION, DISABILITY, AND IMPAIRMENT.

  Patient problems: Abscess; Disability; Unspecified Infection

  MAUDE report 8091568 ↗