VENTRIO 5950010Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741031502), received between Mar 25, 2019 and Jan 13, 2024 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Defective Device” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF SEPRAMESH IP (DEVICE #1). PER OPERATIVE NOTES, ¿UPON INITIAL INSPECTION OF THE HERNIA, IT APPEARED TO BE AN INCISIONAL HERNIA IN THE EPIGASTRIC LOCATION. THERE WAS SOME OMENTUM WITHIN THE HERNIA DEFECT, AND THIS WAS TAKEN DOWN. A SEPRAMESH IP (DEVICE #1) WAS PLACED WITH TACKER AND SUTURED." (B)(6) 2016 - PATIENT VISITED HOSPITAL FOR LEFT AND RIGHT LOWER QUADRANT ABDOMINAL PAIN AND UNDERWENT CT IMAGING. (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT INCISIONAL HERNIA, PERITONEAL ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRIO ST (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIOLYSIS WAS PERFORMED BY TAKING DOWN OMENTUM WHERE IT WAS STUCK TO THE ANTERIOR ABDOMINAL WALL, BOTH IN THE AREA OF PREVIOUSLY PLACED MESH (DEVICE #1) AS WELL AS JUST TO THE ACTUAL PERITONEUM ITSELF. THE HERNIA DEFECT WAS IDENTIFIED AND SEPARATED FROM THE PATIENT¿S PREVIOUS MESH. A VENTRIO ST (DEVICE #2) WAS PLACED INTO THE ABDOMEN WITH TACKER. THE PATIENTS PREVIOUSLY PLACED MESH (DEVICE #1) APPEARED TO BE IN GO

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 18509435 ↗
• InjuryOct 1, 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 UNSPECIFIED BARD/DAVOL VENTRIO ST (X2) ON (B)(6) 2016 (X2) AND 3DMAX AND VENTRALIGHT ST (X3) ON (B)(6) 2018 AND/OR (B)(6) 2019 AND/OR (B)(6) 2019 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST (X2) AND VENTRALIGHT ST (X3). 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); Hernia; Insufficient Information; Pain

  MAUDE report 12562627 ↗
• InjuryDec 11, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT FOLLOWING IMPLANT OF A VENTRIO ST, THE PATIENT DEVELOPED FISTULA, HERNIA, AND UNSPECIFIED INFECTION. IT WAS FURTHER REPORTED THAT THE DEVICE WAS EXPLANTED, AND PATIENT UNDERWENT UNEXPECTED MEDICAL INTERVENTION AND ADDITIONAL SURGERY.

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 10992543 ↗
• InjurySep 28, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL VENTRIO ST MESHES ON (B)(6) 2014 AND (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 10592427 ↗
• InjuryAug 14, 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 ST ON (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRIO ST. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO ST. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED WITH INCARCERATED PERITONEAL FAT WAS EXCISED. THE SAC WAS REDUCED. A VENTRIO ST MESH WAS PLACED USING PROLENE SUTURES AND TACKED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRIO ST AND IMPLANT OF SYNTHETIC MESH. PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED, DISSECTED AND OPENED. THE OMENTUM ADHERENT TO PRIOR MESH WAS TAKEN DOWN. THE PRIOR MESH WITH METAL TACKS WERE REMOVED AND EXCISED ENTIRELY. A SYNTHETIC MESH WAS PLACED AND SUTURED.¿

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

  MAUDE report 10406224 ↗
• InjuryJun 1, 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) 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: Adhesion(s); Injury

  MAUDE report 10107427 ↗
• InjuryApr 2, 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 ST ON (B)(6) 201 (ERROR IN LEGAL CLAIM). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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; Seroma

  MAUDE report 9917674 ↗
• DeathJul 29, 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 PATCH ON (B)(6) 2015. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL VENTRIO PATCH. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS,THE DEVICE WAS DEFECTIVE AND WRONGFUL DEATH.

  Patient problems: Abscess; Adhesion(s); Death; Fistula; Injury; Unspecified Infection

  MAUDE report 8836824 ↗
• InjuryJul 5, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2015 OR (B)(6) 2018, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL VENTRIO ST (DEVICE #2). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST (DEVICE #1) AND VENTRIO ST (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Injury; Pain

  MAUDE report 8764427 ↗
• InjuryMar 29, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  PER LEGAL COMPLAINT: (B)(6) 2014 - PATIENT UNDERWENT SURGERY DURING WHICH THE PATIENT WAS IMPLANTED WITH AN UNSPECIFIED BARD/DAVOL VENTRIO ST. THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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; Pain

  MAUDE report 8465760 ↗
• InjuryMar 25, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2015, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRIO ST. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRIO ST. 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 8449661 ↗