VENTRALIGHT 5991520Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741131004), received between Oct 10, 2018 and Jun 28, 2024 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A PROCEDURE, DUST LIKE FOREIGN MATERIAL WAS FOUND INSIDE THE BOX OF THE VENTRALIGHT ST W/ ECHO 2 MESH. IT WAS REPORTED THAT THE PRODUCT WAS NOT USED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634138 ↗
• MalfunctionJun 21, 2024Break; Break

  AS REPORTED, DURING A ROBOTIC VENTRAL HERNIA REPAIR PROCEDURE, THE VENTRALIGHT ST ECHO 2 PS WAS REMOVED FROM THE PACKAGING, AND ON THE STERILE FIELD IT WAS NOTED THAT A PIECE OF ONE OF THE PURPLE CONNECTORS (THE TAIL OF IT) WAS BROKEN OFF. IT WAS REPORTED THAT THE MESH REMAINED INTACT WITH ALL CONNECTORS AND THE SURGEON WAS ABLE TO USE THE MESH WITHOUT ANY ISSUE. AS REPORTED, THE PIECE THAT BROKE OFF WAS DISCARDED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583920 ↗
• 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) 2023, PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH IMPLANT OF VENTRALIGHT ST W/ECHO 2 POSITIONING SYSTEM. IT WAS REPORTED THE SURGEON REALIZED THAT THE ECHO 2 PS LEFT INSIDE THE PATIENT WHEN PATIENT WAS BEING MOVED OUT OF THE OR THEREBY PATIENT WAS PUT UNDER AGAIN WITH A SMALL RE-OPENING OF INCISION AND ECHO 2 PS WAS REMOVED. THIS FILE REPRESENTS THE EVENT #2.

  Patient problems: Foreign Body In Patient

  MAUDE report 19186211 ↗
• MalfunctionJul 10, 2023Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2023, THE SURGEON NEEDED A LARGER SIZED MESH DURING THE CASE AND WHEN THE OR NURSE REALIZED THE VENTRALIGHT ST W/ ECHO 2 HAD AN EXPIRATION DATE OF 28-MAY-2023, INFORMED THE SURGEON; HOWEVER, THE SURGEON WANTED TO USE THE MESH ANYWAYS AND IMPLANTED THE MESH. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE STERILE PACKAGING AND THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17293363 ↗
• InjuryApr 20, 2023Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  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 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

  MAUDE report 16776170 ↗
• InjurySep 21, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT A VENTRAL INCISIONAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, DURING WHICH A BARD/DAVOL VENTRALIGHT ST W/ECHO 2 WAS USED TO TREAT THE PATIENT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, AND UNDERWENT A CT SCAN. THE CT EXAMINATION REVEALED MESH ADHESION OF THE SMALL INTESTINE AND A DIAGNOSIS OF ILEUS ON THE RIGHT SIDE. ON (B)(6) 2022, THE DOCTOR DECIDED TO FOLLOW UP WITH AN ILEUS TUBE. AS REPORTED, IT IS NOT KNOWN WHETHER THE ADHESION WAS DUE TO THE ROLLING OF THE MESH, ADHESION TO THE MESH COATING, OR IF THE MESH WAS THE CAUSE. THE PATIENT DID NOT UNDERGO ADDITIONAL SURGICAL INTERVENTION DUE TO THIS REPORTED EVENT.

  Patient problems: Abdominal Pain; Adhesion(s); Unspecified Gastrointestinal Problem

  MAUDE report 15461267 ↗
• InjuryMay 24, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORTED PER CLINICAL TRIAL (B)(4). (B)(6) 2020 - SUBJECT PATIENT UNDERWENT AN ROBOTIC ASSISTED FIRST TIME RECURRENT LEFT INCISIONAL HERNIA (7X7 CM) REPAIR PROCEDURE AND IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH USING ECHO PS 2, IN AN ONLAY FASHION INTRA-PERITONEALLY. FULL SKIN CLOSURE WAS ACHIEVED USING SUTURES. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020. (B)(6) 2020 - SUBJECT PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL SEROMA. (B)(6) 2021- SUBJECT PATIENT UNDERWENT AN ULTRASOUND-GUIDED DRAINAGE OF THE SEROMA WITH A PLACEMENT OF JP SUCTION BULB AND WAS DISCHARGED ON THE SAME DAY. (B)(6) 2021 - SEROMA RESOLVED. 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 14488107 ↗
• InjuryFeb 1, 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/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2018 AND (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: Adhesion(s); Hernia; Insufficient Information; Pain

  MAUDE report 13415348 ↗
• MalfunctionOct 7, 2021Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, IT WAS NOTED THAT THE ST COATING PEELED ABOUT 1-2 MM FROM THE EDGE OF THE BARD/DAVOL VENTRALIGHT ST W / ECHO 2 MESH. AS REPORTED, THE SURGEON USED A COUPLE OF ADDITIONAL FASTENERS/FIXATION TO SECURE THE ST COATING IN PLACE, OVER THE MESH. AS REPORTED, THERE WAS NO PATIENT HARM OR INJURY AS A RESULT AND THE SURGEON COMPLETED THE CASE WITHOUT ANY FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12591024 ↗
• MalfunctionJul 22, 2021Expiration Date Error; Expiration Date Error

  AS REPORTED, A BARD/DAVOL VENTRALIGHT ST W/ ECHO 2 POSITIONING SYSTEM WAS USED DURING A PROCEDURE ON (B)(6) 2021. FOLLOWING IMPLANT OF THE MESH IT WAS NOTED THAT THE DEVICE HAD EXPIRED ON 28-JUN-2021. AS REPORTED, THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION POST IMPLANT AND THERE IS NO REPORTED PATIENT INJURY. IT WAS REPORTED THAT THE BOX AND PACKAGING WERE NOTED TO BE INTACT PRIOR TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12211916 ↗
• InjuryOct 31, 2018Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR USING THE VENTRALIGHT STW/ ECHO 2 PS, THE SURGEON INADVERTENTLY LEFT THE ECHO 2 PS POSITIONING SYSTEM IN VIVO AT THE CLOSE OF THE CASE. AS REPORTED THE SURGEON "WOKE UP AT 2AM REALIZING HE HAD LEFT THE DEVICE IN THE PATIENT." THE NEXT DAY, THE SURGEON BROUGHT THE PATIENT BACK TO SURGERY TO REMOVE THE DEVICE. THE ENTIRE ECHO 2 PS WAS REMOVED WITHOUT FURTHER COMPLICATIONS. AS REPORTED THE PATIENT STAYED IN THE HOSPITAL FOR 6 DAYS AND WAS THEN DISCHARGED HOME. THIS WAS THE SURGEON'S FIRST CASE USING THE ECHO 2 PS DEVICE, HOWEVER IS AN ESTABLISHED USER OF THE ECHO (1) DEVICE.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 8026245 ↗
• InjuryOct 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED, ON (B)(6) 2018 THE PATIENT UNDERWENT A ROBOTICALLY ASSISTED VENTRAL INCISIONAL HERNIA REPAIR WITH IMPLANT OF THE VENTRALIGHT ST MESH WITH ECHO 2.0 PS. ABOUT 2 WEEKS LATER, ON (B)(6) 2018 THE PATIENT RETURNED TO THE HOSPITAL AND WAS TAKEN TO SURGERY WHERE THE SURGEON DISCOVERED THE MESH WAS ADHERED TO A PORTION OF THE BOWEL AND THIS WAS CAUSING AN OBSTRUCTION. DUE TO SHORT AMOUNT OF TIME THE MESH HAD BEEN IN PLACE, THE SURGEON WAS ABLE TO SEPARATE THE MESH FROM THE BOWEL AND THERE WAS NO RESIDUAL BOWEL INJURY. THE PATIENT REMAINED HOSPITALIZED FOR OBSERVATION.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 7953680 ↗