VENTRALIGHT 5955460Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00801741031724), received between Apr 6, 2017 and Jul 6, 2026 — classified as 77 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Defective Device” (67 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Apr 25, 2023Open, Classified

   Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

   Z-2242-2023 · Root cause: Under Investigation by firm · FDA record ↗

2. Apr 25, 2023Open, Classified

   Balloon may not inflate as intended. If the balloon does not inflate during laparoscopic ventral hernia repair this may result in a delay or prolongation of the procedure, inadequate mesh placement, erosion/migration, pain and mesh infection

   Z-2241-2023 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• InjuryJul 6, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "AN INCISION WAS MADE IN THE LOW EPIGASTRIUM. AN INCISIONAL AND UMBILICAL HERNIA WERE IDENTIFIED. BOTH THE DEFECTS WERE MADE AS ONE DEFECT WHICH WAS REPAIRED BY PLACING A VENTRALEX ST MESH (DEVICE 1) AND SECURED WITH SUTURES TO THE FASCIAL EDGE." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXCISION OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST WITH ECHO PS (DEVICE 2). PER OP NOTES, "A SMALL TRANSVERSE INCISION WAS MADE. ADHESIONS WERE TAKEN DOWN BETWEEN THE OMENTUM AND THE UNDERSURFACE OF THE OLD HERNIA MESH (DEVICE 1). THE OLD MESH WAS REMOVED AND BISECTED, THERE WERE TWO FASCIAL DEFECTS. A VENTRALIGHT ST WITH ECHO PS (DEVICE 2) WAS PLACED INTO THE PERITONEAL CAVITY AND SECURED AT ITS EDGES AND AT SCATTERED SITES TOWARDS THE MIDDLE WITH THE ABSORBABLE TACKS." ON (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, "INTRA-ABDOMINAL LYSIS OF ADHESIONS WAS MADE. ADHESIONS BETWEE

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 25717288 ↗
• InjuryMay 20, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED, (B)(6) 2005 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA OF THE ABDOMEN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1). PER OPERATIVE NOTES, ¿A TRANSVERSE INCISION WAS MADE IN THE PREVIOUS SCAR IN THE LOWER PART OF THE ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A COMPOSIX KUGEL PATCH (DEVICE 1) WAS PLACED INTO THE PERITONEAL SPACE AND SECURE IT WITH SUTURES.¿ (B)(6) 2007 - PATIENT WAS DIAGNOSED WITH LEFT LOWER QUADRANT ABDOMINAL PAIN, INFLAMMATION, ADHESION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIALLY EXPLANT OF COMPOSIX KUGEL PATCH (DEVICE 1) AND LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿A TRANSVERSE INFRAUMBILICAL INCISION WAS MADE THROUGH THE SKIN AND SUBCUTANEOUS TISSUE. PREVIOUSLY PLACED MESH (DEVICE 1) WAS ADHERED, WHICH WAS EXCISED PARTIALLY. LYSIS OF ADHESION WAS PERFORMED. ALL INFLAMMATIONS WERE REMOVED FROM ABDOMEN. THE HERNIA DEFECT WAS CLOSED WITH SUTURES PRIMARILY.¿ (B)(6) 2010 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE LEFT INGUINAL REGION. THE HERNIA SAC WAS DISSECTE

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 25227481 ↗
• InjuryMar 24, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿IN THE LOWER MIDLINE, THE HERNIA AND RECTUS DIASTASIS WAS NOTED. FEW ADHESIONS OF THE MIDLINE WAS REDUCED AND ADHESIONS TO RECTUS DIASTASIS AND HERNIA SAC WERE FREED. THE INTERNAL HERNIA HERNIATED AROUND THE ADHERENT LOOP OF SMALL BOWEL WAS REDUCED. THE RECTUS DIASTASIS WAS FREED AND ROUND VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED OVER THE DEFECT AND SECURED WITH SUTURES. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES AND OPTIFIX TACKERS.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF KUGEL HERNIA PATCH (DEVICE 2). PER OPERATIVE NOTES, ¿A LOWER MIDLINE INCISION FROM PRIOR SURGERY WAS NOTED. JUST TO THE LEFT OF THE MIDLINE IN THE INGUINAL AREA, A LARGE DIRECT HERNIA IN THE MIDLINE WAS NOTED. THE SAC WAS DISSECTED OFF PREPERITONEAL SPACE AND OVAL PIECE OF KUGEL HERNIA PATCH (DEVICE 2) WAS PLACED OVER THE DEFECT IN THE PREPERITONEAL SPACE AND TACKED TO THE BONE AND MUSCLE AND SUTURED.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24673244 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE OVER THE HERNIA THROUGH SKIN. THE HERNIA SAC WAS DISSECTED OUT. A LARGE VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE PREPERITONEAL SPACE. THE HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE TAKEN DOWN. PREVIOUSLY PLACED VENTRALEX ST MESH (DEVICE 1) WAS CAREFULLY FREED AND EXCISED ENTIRELY. A VENTRALIGHT ST W/ ECHO MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH LARGE RECURRENT VENTRAL HERNIA, ADHESION, SCAR TISSUE, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH EXPLANT OF VENTRALIGHT ST W/ ECHO MESH (DEVICE 2) AND IMPLANT OF BARD SOFT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE ALONG THE MIDLINE FOL

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 24504678 ↗
• MalfunctionFeb 25, 2026Detachment of Device or Device Component

  AS REPORTED PER MEDSUN # (B)(4): "DESCRIBE THE EVENT OR PROBLEM: VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM DEFECTIVE. WHEN MESH WAS ON THE STERILE FIELD AND BEING PLACED IN THE TROCAR FOR PLACEMENT INTO THE ABDOMEN, THE SCAFFOLDING CAME OFF THE MESH MAKING IT IMPOSSIBLE TO BE PLACED DOWN THE TROCAR. IT WAS NOT USED ON PATIENT. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT KNOWN".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24444421 ↗
• MalfunctionJan 9, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE ECHO PS DETACHED FROM THE VENTRALIGHT ST MESH PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020488 ↗
• MalfunctionDec 23, 2025Use of Device Problem; Use of Device Problem

  AS REPORTED, A VENTRALIGHT ST W/ ECHO WITH A LABELED EXPIRATION DATE OF 28-SEP-2025 WAS IMPLANTED IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY, CHANGE IN COURSE OF TREATMENT, OR ANY MEDICAL/SURGICAL INTERVENTION DUE TO THE ISSUE; THE MESH REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877119 ↗
• MalfunctionDec 3, 2025Break; Break

  PER MEDWATCH REPORT #MW5177900 "PERFORMING ROBOTIC UMBILICAL HERNIA REPAIR. BARD VENTRALIGHT MESH WAS PLACED IN PT THROUGH TROCAR. THE [INVALID] ATTACHMENT PIECE WAS PULLED THROUGH ABDOMINAL WALL WITH CARTER T AND THEN BROKE WHILE BEING PULLED. THE SURGEON WAS MADE AWARE. MESH REMOVED AND SENT TO MANAGEMENT. DIFFERENT MESH WAS THEN PLACED FOR PT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23707883 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX (DEVICE #1) MESH. PER OPERATIVE NOTES, ¿THE UMBILICAL HERNIA WAS NOTED AND DISSECTED. A LARGE VENTRALEX MESH (DEVICE #1) WAS PLACED OVER THE DEFECT AND SUTURED IN PLACE.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT SYMPTOMATIC VENTRAL INCISIONAL UMBILICAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL REMOVAL OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS OF OMENTUM AND HERNIA DEFECT WERE REMOVED. THE HERNIA DEFECT IN SUPRAUMBILICAL SIDE WAS NOTED. THE MESH (DEVICE #1) WAS SEEN BUNDLED UP BELOW THE DEFECT. THE PORTION OF THE MESH (DEVICE #1) WAS REMOVED AND VENTRALIGHT ST USING ECHO PS (DEVICE #2) MESH WAS PLACED IN THE EPIGASTRIC AREA AND TACKED CIRCUMFERENTIALLY.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH SMALL BOWEL LACERATION THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESHES (DEVICE #1 AND #2) AND SMALL BOWEL RESECTION. PER OPERATIVE NOTES, ¿THE SMALL BOWEL WAS RESECTED. ADHESIONS AND OLD MESHES (DEVICE #1 AND #3) WERE REMOVED

  Patient problems: Adhesion(s); Bowel Perforation

  MAUDE report 22529135 ↗
• MalfunctionOct 17, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  AS REPORTED, DURING A ROBOTIC VENTRAL HERNIA REPAIR ON (B)(6) 2024, WHILE THE VENTRALIGHT ST MESH W/ ECHO PS INFLATION TUBE WAS BEING PULLED UP THROUGH THE SKIN INCISION THE INFLATION TUBE BROKE, AND THE YELLOW ANCHOR DETACHED. IT WAS REPORTED THAT THE PIECE OF TUBING WITH THE YELLOW ANCHOR WERE FOUND STUCK IN BETWEEN THE SKIN. THE PIECE OF TUBING AND ANCHOR WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING THE SAME MESH AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472781 ↗
• InjuryOct 15, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER ADDITIONAL INFORMATION PROVIDED: ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH INFRAUMBILICAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA WAS NOTED JUST BELOW THE RIGHT UMBILICUS ABOVE A PREVIOUS MIDLINE SCAR. A VERY THICK HERNIA SAC FOUND WAS FREED UP CIRCUMFERENTIALLY DOWN AND EXCISED. A LARGE CIRCULAR PIECE OF COMPOSIX KUGEL MESH (DEVICE #1) PLACED INTRAABDOMINALLY WITH POLYPROPYLENE PORTION DIRECTED ANTERIORLY TACKED IT TO THE ANTERIOR ABDOMINAL WALL AND SUTURED.¿ ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH SEVERE ABDOMINAL PAIN. ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH THE EXPLANT OF COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿ADHESIOLYSIS WAS PERFORMED IN THE RIGHT SIDE. THERE WAS SMALL BOWEL ADHERED TO THE MESH. THEN, THE MESH DISSECTED FROM THE ABDOMINAL WALL AND REMOVED. THE FASCIAL DEFECT WAS IDENTIFIED AND SYNTHETIC MESH WAS SECURED TO THE POST FASCIA AND SUTURED CIRCUMFERENTIALLY AS WELL AS CENTER OF THE MESH.¿ ON (B)(6) 2017: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY

  Patient problems: Adhesion(s); Pain

  MAUDE report 20449469 ↗
• MalfunctionJul 1, 2024Break; Break

  AS REPORTED, DURING VENTRAL HERNIA REPAIR, WHILE USING A VENTRALIGHT ST W/ ECHO PS THE SURGEON PULLED THE INFLATION TUBE UP THROUGH THE PATIENT'S ABDOMINAL WALL SKIN INCISION AND THE INFLATION TUBE "SNAGGED AND THEN BROKE." A SMALL PIECE (APPROX. 3 CM) FELL IN BETWEEN THE PATIENT'S SKIN INCISION. ONCE, THE ECHO PS WAS INFLATED AND THE MESH WAS FIXATED THE SURGEON DECIDED TO LOCATE THE PIECE OF INFLATION TUBE, REMOVED IT AND COMPLETED THE CASE WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645327 ↗
• InjuryFeb 27, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1). PER OPERATIVE NOTES, ¿LOOP OF BOWEL ADHERENT WAS REDUCED AND FREED FROM HERNIA. THE BOWEL APPEARED TO BE INTACT. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1) WAS PLACED INTO THE ABDOMEN AND TACKED.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS OPENED. THERE WAS SOME BOWEL ADHESED UP TO THE LATERAL INFERIOR ASPECT WHERE THE MESH WAS PLACED. VENTRALIGHT ST MESH USING ECHO PS (DEVICE #1) WAS NOT REMOVED AS IT WAS FOUND TO BE INTACT AND WELL INCORPORATED. A VENTRALEX ST MESH (DEVICE #2) WAS PLACED INTO THE ABDOMEN AND SUTURED.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿DISSECTION WAS CARRIED DOWN TO THE MESH AND FREED UP THE ANTERIOR ASPECT OF THE UPPER PORTION OF THE MESH. HERNIAS WERE IDENT

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18786313 ↗
• InjuryFeb 16, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿VENTRAL HERNIA WAS IDENTIFIED SUPERIOR TO UMBILICUS CONTAINING INTRA-ABDOMINAL FAT AND WAS REDUCED. A VENTRALEX MESH (DEVICE #1) WAS SECURED CIRCUMFERENTIALLY AND HERNIA SAC WAS CLOSED OVER THE MESH.¿ ON (B)(6) 2015 - PATIENT VISITED HOSPITAL FOR WOUND EVALUATION AND HAD SOME DRAINAGE OUT OF THE SUPERIOR MARGIN OF THE INCISION. ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2) AND REMOVAL OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WERE ADHESIONS TO THE PREVIOUSLY PLACED VENTRALEX MESH (DEVICE #1) AND WERE DISSECTED OUT. A SMALL DEFECT WAS NOTED INFERIOR AND TO RIGHT LATERAL SIDE OF THE MESH (DEVICE #1) CONTAINED INCARCERATED OMENTUM WHICH WAS CAREFULLY REMOVED. THE VENTRALEX MESH (DEVICE #1) WAS REMOVED FROM THE ABDOMEN. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #2) WAS PLACED AND TACKED TO THE ANTERIOR ABDOMINAL WALL COVERING THE

  Patient problems: Bacterial Infection; Cellulitis

  MAUDE report 18718986 ↗
• InjuryDec 15, 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) 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: Adhesion(s); Hernia; Insufficient Information; Obstruction/Occlusion

  MAUDE report 18333400 ↗
• InjuryNov 16, 2023Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH COMPLEX VENTRAL HERNIA AND UNDERWENT LAPAROSCOPIC HERNIOPLASTY WITH IMPLANT OF COMPOSIX E/X (DEVICE #1) AND VENTRALEX MESH (DEVICE #2). PER OPERATIVE NOTES, "NOTED 3 SEPARATE SMALL FASCIAL DEFECTS AT UMBILICUS, SUPRAUMBILICUS SPACE AND ONE JUST TO THE RIGHT OF SUPRAUMBILICUS SPACE. THEN THE ABDOMINAL FASCIAL DEFECTS WAS TAKEN DOWN. A COMPOSIX E/X (DEVICE #1) MESH WAS PLACED INTO THE PERITONEAL CAVITY WITH POLYPROPYLENE SIDE TO THE ABDOMINAL FACIA. A SMALL VENTRALEX MESH (DEVICE #2) WAS PLACED INTRACORPOREALLY TO COVER THE FASCIAL DEFECT AND TACKED." (B)(6) 2016 - PATIENT UNDERWENT ROBOTIC VENTRAL INCISIONAL HERNIA REPAIR WITH PLACEMENT OF VENTRALIGHT ST MESH WITH ECHO PS (DEVICE #3) AND EXPLANT OF EXISTING HERNIA MESHES (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE UPPER ABDOMINAL PORTION OF THE MESH (DEVICE #2) WAS FAIRLY WELL INCORPORATED HOWEVER THERE WERE MULTIPLE OMENTAL ADHESIONS AND WERE LYSED. ALONG THE LOWER ASPECT OF THE MESH, THERE WERE SEVERAL LOOPS OF SMALL BOWEL ADHERENT TO THE MESH (DEVICE #1). AFTER LYSIS OF ADHESIONS, THE RECURRENT HERNIA WAS LOCATED IN THE INFERIOR ASPECT OF THE

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

  MAUDE report 18146683 ↗
• InjuryOct 10, 2023Defective Device; Patient-Device Incompatibility; 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 ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST VENTRALIGHT ST. 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: Abdominal Pain; Adhesion(s); Fistula; Insufficient Information; Pain; Seroma

  MAUDE report 17902890 ↗
• InjurySep 25, 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) 2022. AS REPORTED THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST. ATTORNEY ALLEGES THAT THE PATIENT HAD REVISION SURGERY ON (B)(6) 2023. 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: Abdominal Pain; Hernia; Insufficient Information; Pain

  MAUDE report 17807107 ↗
• InjuryMay 12, 2023Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Migration; Device Appears to Trigger Rejection; 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) 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); Hernia; Insufficient Information

  MAUDE report 16918687 ↗
• InjuryOct 28, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, A BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS WAS IMPLANTED IN THE PATIENT. AS REPORTED, WHEN THE CASE WAS COMPLETED, THE OR CIRCULATOR IDENTIFIED THAT THE ECHO PS WAS NOT REMOVED FROM THE PATIENT. AS REPORTED, THE PATIENT WAS TAKEN BACK INTO THE OR ON THE SAME DAY AND THE ECHO PS WAS REMOVED WITHOUT ANY FURTHER ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690009 ↗
• InjuryJul 11, 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 3DMAX MESH AND VENTRALIGHT ST ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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 14976612 ↗
• InjuryJun 1, 2022Migration or Expulsion of Device; Defective Device; Material Deformation; Patient Device Interaction Problem; Migration or Expulsion of Device; Defective Device; Material Deformation; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL MESH AND A BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS (MESH PRODUCTS). ATTORNEY ALLEGES THAT ON OR ABOUT (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A NON-BARD/DAVOL MESH TO REPAIR A VENTRAL HERNIA. IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2017, THE PATIENT UNDERWENT RECURRENT VENTRAL HERNIA REPAIR, REMOVAL OF THE NON-BARD/DAVOL MESH AND WAS IMPLANTED WITH A BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS. "AS A DIRECT AND PROXIMATE RESULT OF DEFENDANTS¿ DEFECTIVE DESIGN, MANUFACTURE, MARKETING, DISTRIBUTION, AND/OR SALE OF NON-BARD/DAVOL MESH AND THE VENTRALIGHT ST MESH W/ ECHO PS AND PLACING THE DEFECTIVE PRODUCTS INTO THE STREAM OF COMMERCE, THE PATIENT HAS BEEN INJURED AND DAMAGED AS FOLLOWS": IT IS ALLEGED THAT ON OR ABOUT (B)(6) 2021, THE PATIENT UNDERWENT REVISION OF THE BARD/DAVOL VENTRALIGHT ST MESH W/ ECHO PS. IT IS ALLEGED THAT THE PATIENT EXPERIENCED AND/OR CONTINUES TO EXPERIENCE SEVERE AND CHRONIC PAIN/DISCOMFORT, MESH MIGRATION, MESH CURLING, DENSE ADHESIONS, LOOPS OF BOWEL ADHERED TO MESH, RECURRENCE, AND MESH REMOVAL. IT IS ALLEGED THAT THE PATIENT CONTINUES TO SUFFER COMPLICATION AS A RESULT OF IMPLANTATI

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

  MAUDE report 14569100 ↗
• InjuryApr 13, 2022Defective Device; 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) 2016 AND (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.

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

  MAUDE report 14102444 ↗
• 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 AN UNSPECIFIED BARD/DAVOL VENTRALIGHT ST WITH ECHO ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE VENTRALIGHT ST WITH ECHO. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 13829356 ↗
• InjuryMar 8, 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 SEPRAMESH IP, VENTRALIGHT ST AND VENTRIO ST ON (B)(6) 2014 AND/OR (B)(6) 2015 AND/OR (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE SEPRAMESH IP AND 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 13693259 ↗