VENTRALIGHT 5992025Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741131042), received between Mar 20, 2018 and Sep 3, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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.

• InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025, A VENTRALIGHT ST MESH W/ ECHO 2 WAS USED DURING A PROCEDURE. AS REPORTED THE MESH WAS "PLACED ON THE SECOND INTESTINE." ADHESIONS WERE OBSERVED APPROXIMATELY TWO WEEKS POST-IMPLANTATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION AND THE ADHESIONS BETWEEN THE MESH AND THE INTESTINE WERE SURGICALLY REMOVED. DURING THIS PROCEDURE THERE WAS NO PLACEMENT OF AN ADDITIONAL MESH. THERE WAS NO PATIENT INJURY, AND THE CURRENT STATUS OF THE PATIENT IS STABLE WITH NO ONGOING ISSUES.

  Patient problems: Adhesion(s)

  MAUDE report 22955768 ↗
• InjuryMay 23, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE: "LAPAROSCOPIC INTRAPERITONEAL MESH REPAIR OF A LARGE INCISIONAL HERNIA IN A KIDNEY TRANSPLANTATION PATIENT: A CASE REPORT". THE ARTICLE REPORTS A CASE REGARDING A LARGE INCISIONAL HERNIA IN A 73-YEAR-OLD KIDNEY TRANSPLANT PATIENT BEING SUCCESSFULLY TREATED BY MINIMALLY INVASIVE LAPAROSCOPIC IPOM REPAIR. THE ARTICLE NOTES THAT THE KIDNEY TRANSPLANT WAS PERFORMED WHEN THE PATIENT WAS 40 YEARS OLD AND HAS BEEN MAINTAINED ON IMMUNOSUPPRESSIVE THERAPY WITH PREDNISONE AND TACROLIMUS. FIFTEEN YEARS POST-TRANSPLANT, THE PATIENT WAS DIAGNOSED WITH AN INCISIONAL HERNIA IN THE LATERAL ASPECT OF THE TRANSPLANT INCISION THAT HAD GRADUALLY AND PAINFULLY INCREASED IN SIZE. THE COMPLEX HERNIA REPAIR (AT AGE 73) WAS COMPLETED USING A BD/BARD VENTRALIGHT ST WITH ECHO 2 MESH, FIXATED USING A BD/BARD CAPSURE STRAIGHT FIXATION DEVICE. AS REPORTED ¿POSTOPERATIVELY, A SUBCUTANEOUS SEROMA DEVELOPED IN THE DEAD SPACE OF THE INCISED HERNIA AND RESOLVED 10 WEEKS LATER WITHOUT INTERVENTION. ALTHOUGH THE BULGING WAS MILDLY ADMITTED, THE ABDOMINAL WALL ALMOST RETURNED TO ITS ORIGINAL STATE, AND THE PATIENT'S BODY CONTOUR IMPROVED. ONE YEAR AFTER THE OPERATION, THE PATIENT HAS NOT EXPERIENCE

  Patient problems: Seroma

  MAUDE report 16987259 ↗
• InjuryOct 21, 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 VENTRALIGHT ST MESHES ON (B)(6) 2015 AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Insufficient Information; Pain

  MAUDE report 12674272 ↗
• InjuryMay 27, 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 VENTRALIGHT ST AND PHASIX ST ON (B)(6) 2020 AND/OR (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT 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.

  Patient problems: Adhesion(s); Fistula; Granuloma; Hernia; Insufficient Information; Sepsis; Unspecified Infection

  MAUDE report 11895293 ↗
• InjuryJul 8, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALEX ST AND VENTRALIGHT ST ON (B)(6) 2015 AND/OR (B)(6) 2019. 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) 2019 DUE TO HERNIA MESH DEVICE. 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 10244572 ↗
• MalfunctionMar 6, 2020Material Separation; Material Separation

  AS REPORTED DURING A ROBOTIC FLANK HERNIA PROCEDURE ON (B)(6) 2020, THE SURGEON WHO IS A FIRST TIME USER OF THE BARD VENTRALIGHT ST W /ECHO 2, NOTED AFTER 5-10 MINUTES OF MESH HANDLING THAT THE BARRIER OF THE DEVICE WAS SCRAPING OFF. CUSTOMER REPORTS THAT THE MESH WAS HYDRATED PRIOR TO USE. AS REPORTED A 12MM TROCAR WAS BEING USED IN THE FIELD, BUT THE "MESH TECHS AND SURGEON WERE UNABLE TO GET THE MESH DOWN THE TROCAR AND THEY TRIED A FEW DIFFERENT TIMES."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9801966 ↗
• MalfunctionDec 24, 2019Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A VENTRAL HERNIA REPAIR CASE PERFORMED ON (B)(6) 2019 THE VENTRALIGHT ST W/ ECHO 2 PS MESH WAS PLACED IN THE ABDOMEN AND FASTENED INTO PLACE USING THE CAPSURE AND OPTIFIX AT FIXATION DEVICES. THE SURGEON BEGAN TO PULL ON THE FRAME FOR REMOVAL AND IS REPORTED TO HAVE PULLED TO THE VERY RIGHT OF THE AREA ON THE FRAME THAT SAYS "REMOVE". AS THE SURGEON WAS REMOVING THE FRAME THE ARM BROKE OFF AND HE NOTED A BLUE COIL (CONNECTOR) TO BE LAYING IN THE ABDOMINAL SPACE, BY ITSELF, FREE FROM THE FRAME. THE SURGEON CONTINUED TO REMOVE THE FRAME AND THE DETACHED PIECES. THERE WERE NO LOOSE PIECES OF THE FRAME LEFT IN THE PATIENT AND NO ADDITIONAL INTERVENTIONS HAD TO BE TAKEN TO REMOVE THE PIECES. THE MESH REMAINED IMPLANTED IN THE ABDOMEN. THIS WAS THE SURGEONS FIRST TIME USING THE ECHO 2 PS DEVICE. THE SURGEON DOES HAVE EXPERIENCE WITH THE ECHO 1 PS DEVICE. AS REPORTED THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9516695 ↗
• MalfunctionJun 27, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2019 THE POSITIONING SYSTEM OF A BARD VENTRALIGHT ST W/ ECHO 2 PS PARTIALLY DETACHED JUST AFTER THE DEVICE WAS INSERTED INTO THE ABDOMINAL CAVITY THROUGH A 12MM TROCAR. THE ENTIRE ECHO 2 PS WAS REMOVED WITHOUT ISSUE AND FIXATION WAS PERFORMED MANUALLY. AS REPORTED SURGEON WAS A FIRST TIME USER OF THE DEVICE AND THE MESH WAS ROLLED AND INSERTED IN THE CORRECT FASHION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8739974 ↗
• InjuryApr 8, 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 VENTRALIGHT ST ON (B)(6) 2017. IT IS ALSO ALLEGED BY PATIENT'S ATTORNEY THAT ON (B)(6) 2017, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE VENTRALIGHT ST, AND UNDERWENT REVISION SURGERY. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT 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: Abscess; Bacterial Infection; Disability; Injury; Pain

  MAUDE report 8492987 ↗
• MalfunctionMar 20, 2018Use of Device Problem; Torn Material; Use of Device Problem; Torn Material

  IT WAS REPORTED THAT ON (B)(6) 2018 A BDI SURGICAL / DAVOL VENTRALIGHT ST W/ ECHO 2 DEVICE WAS BEING USED IN A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE. AS REPORTED THE MESH WAS FIXATED AND THEN THE SURGEON ATTEMPTED TO PULL THE FRAME FROM THE MESH WHILE THE HOISTING SUTURE WAS STILL CLAMPED AT THE SKIN LEVEL AND DUE TO THIS THE SURGEON MET SOME RESISTANCE. WHEN HE PULLED "SWIFTLY" THE ARM (STRUT) TORE FROM THE DEVICE. THE DEVICE WAS REMOVED WITH NO LOOSE PARTS LEFT BEHIND. THERE WAS NO PATIENT INJURY. AS REPORTED THERE WAS A MATERIAL SEPARATION, AS SUCH THERE WAS THE POSSIBILITY FOR AN UNINTENDED FRAGMENT TO FALL INTO THE BODY OR BE LEFT IN VIVO. AN MDR IS FILED TO DOCUMENT THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7355683 ↗