VENTRALIGHT 5990015Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741130991), received between Oct 17, 2017 and Sep 17, 2026 — classified as 7 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Patient-Device Incompatibility

  Addendum per additional information provided:(b)(6) 2018 - Patient was diagnosed with incarcerated incisional hernia thereby underwent laparoscopic repair with implant of Ventralight ST with Echo 2 (Device 1 and 2). Per op notes, "There was significant abdominal adhesions to the midline were taken down. All the adhesions between the small bowel, colon and omentum to the multiple large midline hernias throughout the entire incision was taken down. The hernias were reduced. Two separate pieces of Ventralight ST with Echo 2 (Device 1 and 2) were placed to cover the defect and sutured."(b)(6) 2020 - Patient was diagnosed with recurrent incarcerated incisional hernia with abdominal pain thereby underwent laparoscopic repair with implant of Ventralight ST with Echo 2 (Device 3). Per op notes, "Dense intra-abdominal adhesions of the small bowel to the anterior abdominal wall and the previously placed mesh (Device 1 and 2) were taken down. All the adhesions were taken down. There are multiple hernias along the abdominal wall. The old meshes (Device 1 and 2) were seen densely incorporated into abdominal wall. No attempt was made to remove the old mesh. A Ventralight ST with Echo 2 (Device 3

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

  MAUDE report 50798269 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  As reported, the patient underwent implant of Ventralight ST w/ Echo 2 on (b)(6)2025. Post implant the patient developed hives and had abdominal pain which has not resolved. Reportedly, the surgeon was able to obtain mesh for reactivity testing.

  Patient problems: Abdominal Pain; Urticaria

  MAUDE report 50258077 ↗
• MalfunctionFeb 7, 2025Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR USING A VENTRALIGHT ST W/ ECHO 2 PS, THE DEVICE WAS QUICKLY DIPPED (1-3 SEC) IN SALINE PRIOR TO USE. THE MESH WAS THEN ROLLED PER IFU WITH THE ST COATING ON THE INSIDE. THE DEVICE WAS THEN INSERTED INTO A 12MM TROCAR. IT WAS REPORTED THAT AFTER INSERTING IT THROUGH THE TROCAR, WHEN PULLING UP AGAINST THE PATIENT'S ABDOMINAL WALL, THE SURGEON NOTICED THE ST COATING WAS SLOUGHED OFF IN SOME AREAS. AS REPORTED, THE SURGEON REMOVED THE MESH, AND A NEW MESH WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21331885 ↗
• MalfunctionDec 12, 2023Break; Break

  AS REPORTED, DURING A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE, A VENTRALIGHT ST W/ ECHO 2 POSITIONING SYSTEM WAS USED. AFTER FIXATING THE MESH AND REMOVING THE POSITIONING FRAME THROUGH THE 8MM TROCAR IT WAS NOTED THAT A PIECE OF THE FRAME BROKE/TORE OFF. THE SURGEON FOUND THE PIECE RESTING ON TOP OF THE BOWEL AND IT WAS REMOVED WITH NO INJURY TO THE PATIENT. AS REPORTED THE SURGEON HAD TROUBLE LOCATING THE BROKEN PIECE AND HAD CONCERN OF FRAGMENTS STILL IN THE ABDOMEN. REPORTEDLY IT WAS UNCLEAR TO THE USER IF THE POSITIONING SYSTEM WAS ACCIDENTALLY CUT DURING REMOVAL.

  Patient problems: Foreign Body In Patient

  MAUDE report 18314732 ↗
• MalfunctionJun 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE, A BARD/DAVOL VENTRALIGHT ST W/ECHO PS 2 WAS USED. IT IS REPORTED THAT ONE OF THE BLUE TABS (CONNECTORS) WAS CUT AND FLEW OUT OF THE STERILE FIELD AFTER PULLING THE ECHO PS 2 OUT OF THE TROCAR. THE MISSING BLUE TAB (CONNECTOR) WAS FOUND. AS REPORTED, THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14776768 ↗
• MalfunctionMay 20, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL DVL-HE-020: (B)(6) 2021 SUBJECT PATIENT UNDERWENT ROBOTIC ASSISTED PROCEDURE FOR PRIMARY SUPRAUMBILICAL VENTRAL HERNIA REPAIR. THE SIZE OF THE HERNIA DEFECT WAS 4CM X 3CM. A BARD/DAVOL VENTRALIGHT ST W/ECHO PS 2 WAS IMPLANTED USING A MECHANICAL SUTURE AND THE FASCIA WAS COMPLETELY CLOSED. THE PATIENT WAS DISCHARGED ON THE SAME DAY. (B)(6) 2021 SUBJECT PATIENT WAS DIAGNOSED WITH SMALL SEROMA DURING A FOLLOW-UP VISIT. PER THE STUDY CLINICIAN, THE REPORTED ADVERSE EVENT HAS BEEN ASSESSED AS MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE INDEX PROCEDURE. THE OUTCOME FOR THIS AE IS REPORTED AS RECOVERED/RESOLVED.

  Patient problems: Seroma

  MAUDE report 14456705 ↗
• InjuryMar 20, 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2020. 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: Insufficient Information; Pain

  MAUDE report 13829056 ↗
• InjuryMar 19, 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 UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2020. 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: Hernia; Insufficient Information; Pain

  MAUDE report 13825220 ↗
• InjuryFeb 16, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, WHEN THE BARD/DAVOL VENTRALIGHT ST W/ECHO 2 MESH WAS INSERTED WITH THE INTRODUCER TOOL, THE INTRODUCER TOOL HIT AND NICKED BOWEL AS SURGEON WAS PUSHING THE INTRODUCER TOOL THROUGH THE TROCAR AT THE INCISION SITE. AS REPORTED, THE SURGEON REMOVED THE INTRODUCER TOOL AND DID NOT PLACE THE BARD/DAVOL VENTRALIGHT ST W/ECHO 2 MESH, INSTEAD BARD/DAVOL PHASIX ST ECHO 2 WAS USED AFTER THE BOWEL WAS REPAIRED USING SILK SUTURE.

  Patient problems: Bowel Perforation

  MAUDE report 13544622 ↗
• MalfunctionAug 6, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH A 2 CM DEFECT ON (B)(6) 2021, THE SURGEON USED A BARD/DAVOL VENTRALIGHT ST MESH W/ECHO 2 POSITIONING SYSTEM. AS REPORTED, A 10MM CAMERA PORT AND X2 8MM PORTS WERE USED FOR THE MESH INSERTION/REMOVAL. FOLLOWING PLACEMENT AND FIXATION OF THE VENTRALIGHT ST MESH, THE SURGEON ATTEMPTED TO REMOVE THE ECHO 2 PS FRAME THROUGH THE 8 MM PORT, AND ONE OF THE "SPOKES" DETACHED FROM THE FRAME. THE DETACHED PORTION (SPOKE) OF THE FRAME WAS COMPLETELY REMOVED ALONG WITH THE REST OF THE FRAME AND THERE WAS NO DELAY IN THE CASE. THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12287314 ↗
• MalfunctionApr 22, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON (B)(6) 2021 DURING AN UMBILICAL HERNIA REPAIR PROCEDURE, A BARD/DAVOL VENTRALIGHT ST W/ECHO 2 POSITIONING SYSTEM (PS) WAS USED. AFTER SUCCESSFULLY FIXATING THE MESH, THE PS FRAME WAS REMOVED AND THE SURGEON NOTED A PIECE OF PLASTIC STICKING TO THE MESH SURFACE. AS REPORTED, THE SURGEON REMOVED THE PIECE AND PLACED INTO A SPECIMEN CUP. THE MESH WAS SUCCESSFULLY IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11708743 ↗
• InjuryOct 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 VENTRALIGHT ST ON (B)(6) 2017. 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: Adhesion(s); Hernia; Injury; Obstruction/Occlusion

  MAUDE report 10613275 ↗
• InjurySep 28, 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 VENTRALIGHT ST (X2) ON (B)(6) 2019 AND (B)(6) 2020. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED 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: Hernia; Injury

  MAUDE report 10591679 ↗
• MalfunctionJan 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019 FOLLOWING AN UNSPECIFIED PROCEDURE USING A BARD VENTRALIGHT ST W/ ECHO 2 PS A COUNT WAS TAKEN AND THE ECHO PS WAS NOTED TO BE MISSING ONE OF THE SEVEN (7) MESH TO FRAME CONNECTERS. AS REPORTED A COUNT OF SEVEN (7) WAS MADE PRIOR TO THE PROCEDURE AND AT THE END OF THE PROCEDURE THEY ONLY ACCOUNTED FOR SIX (6). THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8286300 ↗
• MalfunctionOct 17, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT THE REPAIR OF LAPAROSCOPIC INCISIONAL HERNIA WITH A BARD VENTRALIGHT ST W/ ECHO 2 POSITIONING SYSTEM (PS). THIS WAS THE SURGEONS FIRST USE OF THE DEVICE. ONCE INTRODUCED INTO THE ABDOMEN THE DEVICE OPENED AS INTENDED. THE SURGEON USED A SUTURE PASSER GOING INTO THE ABDOMEN THROUGH THE CENTER OF THE DEFECT, SHE GRASPED THE SUTURE THAT IS ATTACHED TO THE DEVICE AND PULLED IT OUT. SHE THEN CHOSE TO CLOSE THE PRIMARY DEFECT, WHILE THE ECHO 2 PS SUTURE WAS IN THE CENTER OF THE DEFECT, BUT PRIOR TO HOISTING UP THE DEVICE AGAINST THE ABDOMINAL WALL TO FIXATE. AFTER CLOSING THE DEFECT THE DEVICE WAS THEN HOISTED UP INTO PLACE AND FIXATED. WHEN READY TO REMOVE THE ECHO 2 PS PORTION OF THE DEVICE, THE CLAMP HOLDING THE SUTURE OUTSIDE THE BODY WAS RELEASED. THE SURGEON DID NOT CUT THE SUTURE CLOSE TO THE BODY AS INSTRUCTED IN THE IFU. WHEN PULLING THE ECHO 2 PS OFF THE MESH IT BEGAN TO RELEASE, BUT THEN THE USER FELT RESISTANCE. SHE LET GO OF THE FRAME OF THE ECHO 2 PS AND GRASPED THE CENTER STRUT AND THE ATTACHED SUTURE. PULLED IT THREE TIMES AND UPON THE THIRD TUG THE STRUT TORE. IT WAS REPORTED THAT THE SUTURE WAS PULLED FREE. THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954218 ↗