VENTRALIGHTRecalls & reported problems across all models

We found 28 models of VENTRALIGHT by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 1,284 adverse event reports in the FDA's MAUDE database, received between Jun 20, 2014 and Sep 28, 2026 — classified as 4 deaths, 1,052 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Defective Device” (834 reports).

2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

VENTRALIGHT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · 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 · Recall details · FDA record ↗

Most reported VENTRALIGHT problems

VENTRALIGHT models

28 models, most reported first. Each model has its own page with its reports, recalls and device details.

• VENTRALIGHT 5955460

  Laparoscope, general & plastic surgery
  2 recalls91 reports
• VENTRALIGHT 5954460

  Mesh, surgical, polymeric
  157 reports
• VENTRALIGHT 5954680

  Mesh, surgical, polymeric
  1 death143 reports
• VENTRALIGHT 5954450

  Mesh, surgical, polymeric
  131 reports
• VENTRALIGHT 5955680

  Mesh, surgical, deployment balloon
  116 reports
• VENTRALIGHT 5955450

  Mesh, surgical, polymeric
  114 reports
• VENTRALIGHT 5955600

  Mesh, surgical, deployment balloon
  84 reports
• VENTRALIGHT 5954810

  Mesh, surgical, polymeric
  1 death62 reports
• VENTRALIGHT 5955810

  Mesh, surgical, polymeric
  1 death60 reports
• VENTRALIGHT 5955790

  Mesh, surgical, deployment balloon
  57 reports
• VENTRALIGHT 5954113

  Mesh, surgical, polymeric
  31 reports
• VENTRALIGHT 5990011

  Laparoscope, general & plastic surgery
  27 reports
• VENTRALIGHT 5955113

  Mesh, surgical, deployment balloon
  26 reports
• VENTRALIGHT 5954600

  Mesh, surgical, polymeric
  25 reports
• VENTRALIGHT 5954790

  Mesh, surgical, polymeric
  1 death23 reports
• VENTRALIGHT 5955610

  Mesh, surgical, polymeric
  22 reports
• VENTRALIGHT 5954124

  Mesh, surgical, polymeric
  20 reports
• VENTRALIGHT 5954610

  Mesh, surgical, polymeric
  18 reports
• VENTRALIGHT 5955800

  Laparoscope, general & plastic surgery
  17 reports
• VENTRALIGHT 5990015

  Mesh, surgical, polymeric
  15 reports
• VENTRALIGHT 5991015

  Mesh, surgical, polymeric
  13 reports
• VENTRALIGHT 5991520

  Mesh, surgical, deployer
  12 reports
• VENTRALIGHT 5992025

  Laparoscope, general & plastic surgery
  10 reports
• VENTRALIGHT 5954800

  Mesh, surgical, polymeric
  6 reports
• VENTRALIGHT 5955124

  Laparoscope, general & plastic surgery
  1 report
• VENTRALIGHT 5991525

  Mesh, surgical, deployer
  1 report
• VENTRALIGHT 5991823

  Mesh, surgical, deployer
  1 report
• VENTRALIGHT 5990020

  Laparoscope, general & plastic surgery
  1 report

Recent VENTRALIGHT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Patient-Device Incompatibility

  Patient problems: Fatigue; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 50918119 ↗
• 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 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Addendum per additional information provided:(b)(6) 2017 - Patient was diagnosed with bilateral recurrent inguinal hernias thereby underwent laparoscopic repair with the implant of two Ventralight ST Mesh (Device 1 - left and 2 - right). Per op notes, "Two Ventralight ST Mesh (Device 1 and 2) were placed on both left and right inguinal regions of the abdomen using sutures."(b)(6) 2019 - Patient was diagnosed with bilateral recurrent inguinal hernias thereby underwent robotic repair with the implant of two Ventralight ST Mesh using Echo PS (Device 3 - left and 4 - right). Per op notes, "In the left lower quadrant at the site of the recurrent hernia in the direct space. A Ventralight ST Mesh using Echo PS (Device 3 - left) was placed to the cooper's ligament using sutures, the previous mesh (Device 1) was closed partially. In the right lower quadrant, a Ventralight ST Mesh using Echo PS (Device 4 - right) was placed to over lap the previously placed mesh (Device 2). There were adhesions noted in the right side."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50797645 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2017 - Patient was diagnosed with parastomal hernia thereby underwent open repair with implant of Ventralight ST Mesh (Device 1). Per operative notes, "A long midline skin incision was made and brought down sharply through fascia. There was some previously placed mesh identified which was intact. There were several adhesions. The hernia sac was dissected out. A Ventralight ST Mesh (Device 1) was placed into the abdominal cavity and secured it with sutures."(b)(6) 2018 - Patient was diagnosed with recurrent parastomal hernia with partial obstruction, seroma, adhesion, thereby underwent open repair with implant of Ventralight ST Mesh (Device 2). Per operative notes, "A midline incision was made through old incision site. The hernia sac was dissected out. There was a small chronic seroma in the midportion of the wound. There was some moderate number of adhesions in the small bowel to the midline wound, all adhesions were taken down sharply. There was small bowel, which was obstructive, all obstructions were taken down. Previously placed Ventralight ST Mesh (Device 1) was identified. A Ventralight ST Mesh (Device 2) was placed into the abdominal wall and

  Patient problems: Abscess; Adhesion(s); Hernia; Obstruction/Occlusion; Scar Tissue; Seroma

  MAUDE report 50588121 ↗
• InjuryAug 27, 2026Migration

  Per information provided:ON (b)(6) 2007 - Patient was diagnosed with umbilical and ventral hernia thereby underwent open repair with the implant of Ventralex Mesh (Device 1). Per op notes, "The umbilicus was mobilized off the fascia. The hernia sac was opened and reduced back into the abdomen. A Ventralex Mesh (Device 1) were placed through the defect against the abdominal wall using prolene sutures."ON (b)(6) 2019 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh using Echo PS (Device 2). Per op notes, "The small bowel which was densely adherent to the prior mesh (Device 1) and suture material. A portion of the mesh and suture were left intact on the surface of the bowel and the bowel was mobilized; adhesions were taken down. A Ventralight ST Mesh using Echo PS (Device 2) was placed in the abdominal cavity using tacks." ON (b)(6)-2019 - Patient was diagnosed with perforated small bowel and abscess thereby underwent repair with removal of mesh (Device 1 and 2). Per op notes, "The patient had moderate abdominal pain. There was adjacent perforation to the mesh (Device 1 and 2) where it had migrated i

  Patient problems: Abdominal Pain; Abscess; Bowel Perforation

  MAUDE report 50482728 ↗
• InjuryAug 27, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with small bowel obstruction, internal hernia, adhesion, incisional hernia thereby underwent open repair with the implant of Bard Flat Mesh (Device 1). Per op notes, "A midline incision was undertaken from the infraumbilical to suprapubic region in the midline. Bands of adhesion causing an internal hernia and twisting of the small bowel adjacent to the hernia consistent with small bowel obstruction as noted. A lightweight Bard Flat Mesh (Device 1) was placed as an only over the fascia and secured using sutures."On (b)(6) 2017 - Patient was diagnosed with multiple ventral hernias thereby underwent robot assisted repair with the implant of Ventralight ST Mesh using Echo (Device 2). Per op notes, "A ventral hernia in the midline near the umbilical region was identified. Nine abdominal wall hernias was noted. A Ventralight ST Mesh using Echo (Device 2) was placed into the defect and secured using tacks."On (b)(6) 2017 - Patient had hiatal hernia, intraabdominal adhesion, bowel stuck to mesh, perforation thereby underwent repair. (Note: There is no op notes provided for this procedure in medical records)

  Patient problems: Adhesion(s); Bowel Perforation

  MAUDE report 50479623 ↗
• InjuryAug 14, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2019 - Patient was diagnosed with incarcerated umbilical hernia with small bowel obstruction thereby underwent open repair with implant of Ventralight ST Mesh (Device 1). Per operative notes, "An incision was made above the umbilicus down towards the umbilicus. Near the umbilicus area the hernia sac was identified and taken down sharply. A Ventralight ST Mesh (Device 1) was placed into the defect and closed the defect with sutures."On (b)(6) 2019 - Patient was diagnosed with small bowel obstruction, adhesions thereby underwent laparoscopic repair with implant of abdominal lysis of adhesions and release of small bowel obstruction. Per operative notes, "An incision was made into the umbilical region. There were some adhesions in the anterior abdominal wall which were taken down sharply. The small bowel obstructions were then released from abdomen. The defect was closed with sutures."On (b)(6 )2020 - Patient was diagnosed with recurrent incisional hernia, thereby underwent robotic assisted laparoscopic repair with implant of Ventralight ST Mesh (Device 2). Per operative notes, "A transverse incision was made in the left upper quadrant. The hernia sac

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

  MAUDE report 50260299 ↗
• 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 ↗
• InjuryAug 5, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2015 - Patient was diagnosed with large ventral hernia thereby underwent laparoscopic repair with the implant of Ventralight ST Mesh using Echo PS (Device 1). Per op notes, "The hernia was reduced from the sac. A Ventralight ST Mesh using Echo PS (Device 1) was placed into peritoneal cavity and overlapped the defect and secured to fascia using SorbaFix tacks."On (b)(6)2016 - Patient was diagnosed with incisional hernia thereby underwent laparoscopic repair. Per op notes, "The mesh (Device 1) was tethered and stuck to the left lobe of the liver was left attached. Lysis of adhesions was done along the central abdomen down to the level of the recurrent ventral hernia. The stomach was found to be adhesed to the hernia contents and the anterior abdominal wall in the lower midline and sleeve was resected."On (b)(6) 2019 - Patient was diagnosed with incisional hernia thereby underwent open repair with the implant of Ventralight ST Mesh (Device 2). Per op notes, "The hernia was noted just to the right of midline. A Ventralight ST Mesh (Device 2) was placed in retrorectus space and sutured the mesh edges to the anterior abdominal wall fascia using sutures.

  Patient problems: Necrosis; Post Operative Wound Infection

  MAUDE report 50140030 ↗
• InjuryAug 3, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with periumbilical ventral hernia thereby underwent laparoscopic repair with the implant of Ventrio ST mesh (Device 1). Per op notes, "A Ventrio ST mesh (Device 1) was placed into the abdominal cavity, secured over the hernia defect and umbilicus with the tacks. "On (b)(6) 2015 - Patient was diagnosed with recurrent ventral hernia thereby underwent laparoscopic repair with the removal of mesh (Device 1) and implant of Ventralight ST Mesh using Echo PS (Device 2). Per op notes, "A lot of omental adhesions to previous mesh that was removed. There was herniation around the peripheral edge of mesh; the previous mesh (Device 1) was removed. A Ventralight ST Mesh using Echo PS (Device 2) was placed to the abdominal cavity using sutures."On (b)(6) 2016 - Patient had abdominal wall defect thereby underwent abdominal wall reconstruction with bilateral myofascial flaps. Per op notes, "The anterior abdominal wall fascia was encountered. The mesh removal would carry the excessive morbidity for the patient. Therefore, the previously placed mesh (Device 2) was left in place. A biologic mesh was then placed."

  Patient problems: Hernia

  MAUDE report 50114027 ↗
• InjuryJul 28, 2026Material Deformation

  Per information provided:(b)(6) 2014 - Patient was diagnosed with multiple incisional hernias from the periumbilical region thereby underwent laparoscopic repair with implant of three Ventralight ST Mesh (Device 1, 2 and 3). Per op notes, "An incision was made in a transverse fashion in the epigastric region just to the left of midline. A small periumbilical hernia was identified. The hernia was present in the superficial layers of the abdominal wall. The adhesions were taken down. Another fascial defect was noted and the source of each of these hernias were cleared back. Defects were noted in the periumbilical area, right hemi-abdomen and midline lower abdomen. The Ventralight ST Mesh (Device 1) was placed to the right hemi-abdomen defect and secured with tack. The midline lower abdominal defect was closed in a similar fashion with an Ventralight ST Mesh (Device 2). The periumbilical area was covered with a second circular Ventralight ST Mesh (Device 3) and secured in with an outer crown and inner crown of tacks."(b)(6) 2018 - Patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with excision of Ventralight ST Mesh (Device 3) and implant of u

  Patient problems: Pain

  MAUDE report 50053188 ↗
• InjuryJul 28, 2026Material Deformation

  Per information provided:(b)(6)2014 - Patient was diagnosed with multiple incisional hernias from the periumbilical region thereby underwent laparoscopic repair with implant of three Ventralight ST Mesh (Device 1, 2 and 3). Per op notes, "An incision was made in a transverse fashion in the epigastric region just to the left of midline. A small periumbilical hernia was identified. The hernia was present in the superficial layers of the abdominal wall. The adhesions were taken down. Another fascial defect was noted and the source of each of these hernias were cleared back. Defects were noted in the periumbilical area, right hemi-abdomen and midline lower abdomen. The Ventralight ST Mesh (Device 1) was placed to the right hemi-abdomen defect and secured with tack. The midline lower abdominal defect was closed in a similar fashion with an Ventralight ST Mesh (Device 2). The periumbilical area was covered with a second circular Ventralight ST Mesh (Device 3) and secured in with an outer crown and inner crown of tacks."(b)(6)2018 - Patient was diagnosed with recurrent umbilical hernia thereby underwent laparoscopic repair with excision of Ventralight ST Mesh (Device 3) and implant of unk

  Patient problems: Pain

  MAUDE report 50052059 ↗
• InjuryJul 28, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2009- Patient was diagnosed with incarcerated incisional hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "Through upper midline incision, hernia sac with incarcerated omentum was identified in the abdominal region which was then reduced. A Ventralex Mesh (Device 1) was placed intraperitoneally and was sutured." On (b)(6) 2011- Patient was diagnosed with chronic pelvis pain, adhesion, thereby underwent robotic assisted laparoscopic repair. Per op notes, "Adhesions from omentum to the anterior abdominal wall was identified. Adhesions were lysed and the omentum was reduced." On (b)(6) 2011- Patient was diagnosed with abdominal pain, adhesion, thereby underwent laparoscopic repair. Per op notes, "Extensive adhesion from the omentum to the previous hernia repair in mid upper abdomen."On (b)(6) 2012- Patient was diagnosed with pelvic pain, adhesion, thereby underwent robotic assisted laparoscopic repair. Per op notes, "Dense adhesions from the omentum to the anterior abdominal wall were identified and the adhesions were lysed."On (b)(6) 2014- Patient was diagnosed with umbilical hernia, thereby underwent exp

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50050074 ↗
• 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 ↗
• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH BILATERAL VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1 AND 2). PER OP NOTES, "THE SUBCOASTAL INCISION WAS MADE. TWO LATERAL VENTRAL WALL HERNIAS WERE IDENTIFIED AND CONSISTENT WITH SPIGELIAN HERNIAS. NO EVIDENCE OF INGUINAL DEFECT WAS NOTED. THE HERNIA SACS WERE REMOVED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED ON RIGHT AND VENTRALIGHT ST MESH (DEVICE 2) WAS PLACED ON LEFT SIDE OF THE ABDOMEN AND TACKED." ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH SPIGELIAN HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, "A PFANNENSTIEL INCISION WAS MADE. THE FASCIA WAS CLEARED TO THE UMBILICUS. THE MIDLINE WAS OPENED AND ADHESIONS TO THE PRIOR MESHES WERE TAKEN DOWN. HERNIA WAS NOT IDENTIFIED BUT RATHER AN EVENTRATION OF THE MESH ON THE RIGHT SIDE (DEVICE 1) WAS NOTED. THE MESH ON THE LEFT (DEVICE 2) WAS LEFT IN PLACE. THE MESH ON THE RIGHT (DEVICE 1) WAS REMOVED, AND THE DEFECT WAS CLOSED WITH SUTURE." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT LOWER QUADRANT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCO

  Patient problems: Adhesion(s); Fibrosis; Hernia; Necrosis; Pain

  MAUDE report 25704652 ↗

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