VENTRALIGHT 5991015Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741130984), received between May 1, 2019 and Oct 29, 2025 — classified as 8 injuries, 5 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, A ROBOTIC VENTRAL HERNIA REPAIR WAS PERFORMED USING THE VENTRALIGHT ST W/ECHO 2. DURING THE PROCEDURE, THE POSITIONING SYSTEM TORE AND COULD NOT BE RELEASED WHEN THE SURGEON WAS APPROACHING THE 12MM TROCAR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412119 ↗
• InjuryMay 7, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM. 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

  MAUDE report 19258453 ↗
• InjuryApr 25, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED PER MEDWATCH REPORT (MW5152956): "IT WAS INCIDENTALLY NOTED ON AN X-RAY, THAT THE EPS POSITIONER FOR THE UMBILICAL HERNIA MESH USED FOR A REPAIR ON (B)(6) 2021, WAS STILL IN THE PATIENT. THIS IS THE 2ND TIME THE FAILURE OF THE SURGEON TO REMOVE THE EPS POSITIONER HAS OCCURRED HERE. IS THERE A BETTER DESIGN FOR REMOVAL OF THE POSITIONER OR THAT WOULD NOT REQUIRE A REMOVABLE POSITIONER? BOTH TIMES, THE POSITIONER WAS REMOVED WITHOUT INCIDENT, BUT DID REQUIRE ADDITIONAL SURGICAL INTERVENTION." PER INFORMATION PROVIDED BY CUSTOMER CONTACT: ON (B)(6) 2021 PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ECHO 2 POSITIONING SYSTEM AND A BILATERAL INGUINAL HERNIA REPAIR WITH MESH JUST PRIOR TO THIS PROCEDURE. ON 09-FEB-2024, ECHO 2 PS INCIDENTALLY DETECTED ON X-RAY AND WAS REMOVED WITHOUT ISSUES ON 06-MAR-2024 AS A SAME DAY SURGERY. THIS FILE REPRESENTS THE EVENT #1.

  Patient problems: Foreign Body In Patient

  MAUDE report 19186234 ↗
• MalfunctionFeb 22, 2023Material Separation; Material Separation

  AS REPORTED, DURING A PROCEDURE WHEN THE SURGEON INSERTED THE VENTRALIGHT ST W/ECHO 2 PS INTO THE PATIENT'S ABDOMEN THROUGH A TROCAR (SIZE IS UNKNOWN), THE POSITIONING SYSTEM CAME APART FROM THE MESH. IT WAS REPORTED THAT THE MESH AND POSITIONING SYSTEM WAS REMOVED FROM THE PATIENT BODY. THE SURGEON USED ANOTHER VENTRALIGHT ST W/ECHO 2 TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16420153 ↗
• InjuryOct 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS PER MDR REPORT: "SURGEON DID NOT REMOVE THE POSITIONING PIECE OF THE MESH WHEN SUTURED INTO PLACE DURING A VENTRAL HERNIA REPAIR. PATIENT HAD TO RETURN TO THE OR FOR REMOVAL. FDA SAFETY REPORT ID # (B)(4)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690032 ↗
• InjuryDec 6, 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 VENTRALIGHT ST ON (B)(6) 2019. 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); Hernia; Insufficient Information; Seroma

  MAUDE report 12944631 ↗
• 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 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: Insufficient Information; Seroma

  MAUDE report 12674281 ↗
• InjuryMay 23, 2021Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSITE MESH (COMPOSIX), COMPOSIX KUGEL HERNIA PATCH AND VENTRALEX ON (B)(6) 2014 AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURIES ON (B)(6) 2014 AND (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: Insufficient Information; Pain

  MAUDE report 11868986 ↗
• MalfunctionApr 14, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED VIA FDA 3500A FORM REPORT ((B)(4)): "DAVOL INC. VENTRALIGHT ST MESH WITH ECHO 2 POSITIONING SYSTEM 10 CM X 15 CM (4" X 6") ELLIPSE WAS BEING INSERTED THROUGH A PORT WHEN PLASTIC PIECE BROKE OFF. THE VENTRALIGHT ST MESH HAS PLASTIC FRAME THAT WAS TOO RIGID/BIG TO FIT THROUGH PORT." THE PROCEDURE BEING PERFORMED WAS A ROBOTIC UMBILICAL HERNIA REPAIR. AS REPORTED DEVICE 1 INTUITIVE SURGICAL 12MM STAPLER CANNULA SEAL 470380. NO ALLEGED PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROBLEM EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11663846 ↗
• InjuryMar 26, 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 VENTRALIGHT ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED UNSPECIFIED INJURY 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); Hernia; Insufficient Information; Obstruction/Occlusion; Pain

  MAUDE report 11573352 ↗
• MalfunctionMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A SURGICAL PROCEDURE ON (B)(6) 2021, THE SURGEON OPENED A BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS 2 AND NOTED THAT THE MESH HAD "UNRAVELED. THE PROCEDURE WAS COMPLETED USING ANOTHER MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396317 ↗
• MalfunctionMay 30, 2019Use of Device Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Use of Device Problem; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019 A FIRST TIME USER OF THE VENTRALIGHT ST W/ ECHO 2 PS WAS PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY AND VENTRAL HERNIA REPAIR. AS REPORTED 8 MM TROCARS WERE PLACED ON BOTH SIDE OF THE ABDOMEN. AFTER SUCCESSFULLY PLACING VENTRALIGHT ST MESH THE SURGEON PULLED ON THE FRAME ABOUT A CM OR 2 FROM THE EDGE TO PULL OUT THROUGH THE 8 MM TROCAR. AS REPORTED THE SURGEON WAS EXERTING ADDITIONAL FORCE WHEN REMOVING THE FRAME. IT WAS NOTED THAT A STRUT DETACHED FROM THE FRAME AND WAS LEFT IN THE TROCAR. THE STRUT WAS LOCATED AND RETRIEVED AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654477 ↗
• InjuryMay 1, 2019Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC VENTRAL INCISIONAL HERNIA REPAIR WITH A VENTRALIGHT ST W/ ECHO 2 PS. THE SURGEON LATER REALIZED HE HAD NOT REMOVED THE ECHO 2 PS PORTION OF THE DEVICE FROM THE IMPLANT. ON (B)(6) 2019 THE PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE FOR REMOVAL OF THE ECHO 2 PS. AS REPORTED THE PROCEDURE WAS UNCOMPLICATED.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8568633 ↗