VENTRALIGHT 5955800Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00801741031779), received between Apr 10, 2018 and Dec 6, 2024 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Defective Device” (9 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2024Defective Device; Patient Device Interaction Problem; Migration; Defective Device; Patient Device Interaction Problem; Migration

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH SUBXIPHOID EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESHES (DEVICE #1 & #2) ON. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS DISSECTED, BECAUSE OF THE HERNIA SIZE TWO LARGE VENTRALEX ST MESHES (DEVICE #1 & #2) WERE PLACED IN THE UPPER PORTION OF THE INCISION IN SUBFASCIAL PLANE WITH TAILS SEWN TO FASCIA AND THE RIMS OF THE MESHES LIE BENEATH THE INFERIOR ASPECT OF THE INCISIONAL HERNIA OVERLAPPED THE COSTAL MARGIN.¿ (B)(6) 2015 - PATIENT HAD POST UP VISIT WITH COMPLAINT OF SWELLING IN THE SUBXIPHOID AREA. (B)(6) 2015 - PATIENT UNDERWENT ULTRASOUND GUIDED CATHETER DRAINAGE OF SUBXIPHOID FLUID COLLECTION, WHICH WAS VISCOUS CLEAR YELLOW FLUID LIKELY REPRESENTS SEROMA, THERE WAS PERSISTENT SUBXIPHOID VENTRAL BULGING WHICH MAY REPRESENT A RECURRENT HERNIA. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT SUBXIPHOID HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH REMOVAL OF OLD MESH (DEVICE #1 & #2) AND IMPLANTED WITH VENTRALIGHT ST MESH USING ECHO PS (DEVICE #3). PER OPERATIVE NOTES, ¿ASPIRATED STRAW-COLORED FLUID FROM THE HERNIA SAC, TAKEN DOWN SEVERAL OMENTAL ADHESIONS

  Patient problems: Bacterial Infection; Hernia; Seroma

  MAUDE report 20861776 ↗
• InjuryNov 21, 2024Inflation Problem; Inflation Problem

  AS REPORTED, DURING A PROCEDURE, AFTER INSERTING THE VENTRALIGHT ST MESH IN THE PATIENT, WHEN THE SURGEON TRIED TO INFLATE THE ECHO PS, THE GREEN BALLOON DID NOT HOLD ANY AIR. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO POSITION OR FIXATE THE MESH, THEN HAD TO REMOVE THE MESH AND BALLOON. THE SURGEON CONVERTED TO AN OPEN PROCEDURE AND PLACED A VENTRIO ST MESH. IT WAS REPORTED THAT AFTER INSPECTING THE GREEN BALLOON, THEY NOTICED A SMALL DEFECT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20746314 ↗
• MalfunctionJun 4, 2024Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING REPAIR OF A HERNIA DEFECT ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH VENTRALIGHT ST MESH USING ECHO PS, THE SURGEON DID NOT CLOSE THE DEFECT AND USED TACKS TO MAKE A DOUBLE CROWN. AS REPORTED A FEW MONTHS LATER, THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE DIRECTLY IN THE MIDDLE OF THE MESH WHERE THE BOWELS WERE PUSHING THROUGH A NEW DEFECT HOLE. ON (B)(6) 2024, THE PATIENT UNDERWENT A REOPERATION BY REMOVING THE COMPLETELY PERITONALIZED MESH. THE HERNIA DEFECT WAS CLOSED WITH SUTURES AND ANOTHER VENTRALIGHT ST MESH WAS USED TO COMPLETE THE REPAIR. REPORTEDLY THE HOLE WAS IN THE MIDDLE OF THE MESH WERE THE TUBING OF THE ECHO PS GOES THROUGH. IT WAS NOTED UPON REVIEW OF THE INFORMATION PROVIDED THAT THE MESH HAS A LABELED EXPIRATION DATE ON 28-OCT-2018 AND WAS IMPLANTED IN (B)(6) 2019. THIS MDR REPRESENTS IMPLANT OF AN EXPIRED MESH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460042 ↗
• InjuryJun 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING REPAIR OF A HERNIA DEFECT ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH VENTRALIGHT ST MESH USING ECHO PS, THE SURGEON DID NOT CLOSE THE DEFECT AND USED TACKS TO MAKE A DOUBLE CROWN. AS REPORTED A FEW MONTHS LATER, THE PATIENT WAS DIAGNOSED WITH A HERNIA RECURRENCE DIRECTLY IN THE MIDDLE OF THE MESH WHERE THE BOWELS WERE PUSHING THROUGH A NEW DEFECT HOLE. ON (B)(6) 2024, THE PATIENT UNDERWENT A REOPERATION BY REMOVING THE COMPLETELY PERITONALIZED MESH. THE HERNIA DEFECT WAS CLOSED WITH SUTURES AND ANOTHER VENTRALIGHT ST MESH WAS USED TO COMPLETE THE REPAIR. REPORTEDLY THE HOLE WAS IN THE MIDDLE OF THE MESH WERE THE TUBING OF THE ECHO PS GOES THROUGH. IT WAS NOTED UPON REVIEW OF THE INFORMATION PROVIDED THAT THE MESH HAS A LABELED EXPIRATION DATE ON 28-OCT-2018 AND WAS IMPLANTED IN (B)(6) 2019. THIS MDR REPRESENTS POST OPERATIVE HERNIA RECURRENCE.

  Patient problems: Hernia

  MAUDE report 19460041 ↗
• InjuryOct 10, 2023Defective 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 MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST MESH. 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: Abscess; Adhesion(s); Hernia; Inflammation; Insufficient Information; Obstruction/Occlusion

  MAUDE report 17903057 ↗
• MalfunctionAug 29, 2023Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE WHEN THE SURGEON WAS PLACING THE VENTRALIGHT ST MESH W/ ECHO PS, THE INFLATION TUBE BROKE WITHIN AN INCH OF THE MESH. IT WAS REPORTED THAT THE SURGEON GRABBED THE LITTLE BIT OF TUBE THAT WAS LEFT AND PLACED A HEMOSTAT ON IT. HOWEVER, THE SURGEON WAS UNABLE TO INFLATE THE BALLOON DUE TO THE INSUFFICIENT LENGTH OF THE TUBE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641390 ↗
• InjuryOct 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2021. 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); Fistula; Inflammation; Insufficient Information; Unspecified Infection

  MAUDE report 15630121 ↗
• InjuryJun 29, 2021Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL COMPOSIX KUGEL HERNIA PATCH ON (B)(6) 2004 AND VENTRALIGHT ST ON (B)(6) 2017. 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. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2004 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL (DEVICE #1). PER OPERATIVE NOTES, ¿SHOWED THE HERNIA DEFECT TO BE JUST ABOVE THE PREVIOUS REPAIR SITE. A COMPOSIX KUGEL HERNIA PATCH (DEVICE #1) WAS PLACED INTO THE INTRAPERITONEAL LOCATION.¿ (B)(6) 2017 -PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESH (DEVICE #1) & IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2). PER OPERATIVE NOTES, ¿THE PATIENT HAD VERY EXT

  Patient problems: Abdominal Pain; Adhesion(s); Bowel Perforation; Fibrosis; Insufficient Information; Necrosis; Pain

  MAUDE report 12083106 ↗
• InjuryJun 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 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Insufficient Information

  MAUDE report 11912610 ↗
• MalfunctionMay 10, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, WHEN THE MATERIALS MANAGER WAS STOCKING INVENTORY, THERE WAS DAMAGE NOTED TO THE PRODUCT CARTON OF A BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS. AS REPORTED, THE PERSON WHO RECEIVED THE PRODUCT IN, STATES THERE WAS NO DAMAGE NOTED TO THE OUTER SHIPPING BOX DURING RECEIPT, BUT THE PRODUCT CARTON INSIDE THE OUTER SHIPPING BOX WAS NOTED TO HAVE A HOLE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11799323 ↗
• InjuryFeb 1, 2021Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST (X2) ON (B)(6) 2013 AND(B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED INJURIES ON (B)(6) 2016. 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 11257011 ↗
• InjuryOct 7, 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, VENTRIO ST AND PHASIX ON (B)(6) 2015 (X2) AND/OR (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST AND PHASIX. 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 10641566 ↗
• InjuryAug 12, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT WAS OPERATED WITH VENTRALIGHT ST W/ ECHO, URGENTLY FOR AN NON-REDUCIBLE UMBILICAL HERNIA THROUGH A LAPAROSCOPIC REDUCTION OF THE UMBILICAL HERNIA AND PLACEMENT OF MESH INTRAPERITONEALLY. THE PATIENT HAD AN UNEVENTFUL POST-OPERATIVE COURSE AND DISCHARGED THE NEXT DAY ((B)(6) 2020). THE 2ND POST-OP DAY ((B)(6) 2020) THE PATIENT COMPLAINED OF VOMITING ABDOMEN DILATATION AND COULD NOT EAT OR DRINK ANYTHING. DURING 3RD POST-OP DAY PATIENT WAS ADMITTED IN THE LOCAL HOSPITAL WITH SYMPTOMS OF OBSTRUCTIVE ILEUS AND WAS OPERATED THE NEXT DAY AND IT WAS REPORTED THAT INTRAOPERATIVE FINDING WERE OBSTRUCTIVE ILEUS DUE TO FIRMLY ADHERENCE OF THE SMALL INTESTINE INTO THE MESH AND IT WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Adhesion(s); Obstruction/Occlusion; Vomiting

  MAUDE report 10395442 ↗
• InjuryFeb 5, 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 THE IMPLANT OF UNSPECIFIED BARD/DAVOL VENTRALIGHT ST ON (B)(6) 2015 AND PHASIX MESH ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9671839 ↗
• InjurySep 25, 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 BARD VENTRALIGHT ST ON (B)(6) 2017. 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: Adhesion(s); Disability; Hernia; Injury; Pain

  MAUDE report 9119971 ↗
• MalfunctionFeb 15, 2019Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  IT WAS REPORTED THAT ON (B)(6) 2019, THE SURGEON IMPLANTED AN EXPIRED VENTRALIGHT ST MESH (W/ ECHO PS) INTO THE PATIENT. THE LABELED EXPIRATION DATE IS 9/28/2018. AS REPORTED DEVICE WAS RECEIVED FROM THE HOSPITAL INVENTORY AND THERE WAS NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION AND NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8343818 ↗
• MalfunctionApr 10, 2018Shelf Life Exceeded; Use of Device Problem; Shelf Life Exceeded; Use of Device Problem

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING A LAPAROSCOPIC REPAIR OF AN INCARCERATED VENTRAL HERNIA A DAVOL VENTRALIGHT ST W/ ECHO WAS IMPLANTED THAT HAD BEEN RETRIEVED FROM THE HOSPITAL INVENTORY. AS REPORTED, AFTER THE PROCEDURE WAS COMPLETED, DURING A ROUTINE DOCUMENTATION OF THE DEVICES USED IN THE PROCEDURE IT WAS NOTED THE EXPIRATION DATE OF THE MESH WAS (B)(6) 2018. AS REPORTED THE SURGEON DECIDED TO LEAVE THE MESH IMPLANTED WITH NO FURTHER MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412924 ↗