VENTRALEXRecalls & reported problems across all models

We found 6 models of VENTRALEX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 2,360 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2013 and Sep 30, 2026 — classified as 9 deaths, 2,283 injuries, 68 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2,063 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. 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

Most reported VENTRALEX problems

VENTRALEX models

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

• VENTRALEX 0010302

  Mesh, surgical, polymeric
  4 deaths531 reports
• VENTRALEX 0010301

  Mesh, surgical, polymeric
  1 death466 reports
• VENTRALEX 0010303

  Mesh, surgical, polymeric
  1 death419 reports
• VENTRALEX 5950009

  Mesh, surgical, polymeric
  2 deaths378 reports
• VENTRALEX 5950008

  Mesh, surgical, polymeric
  1 death321 reports
• VENTRALEX 5950007

  Mesh, surgical, polymeric
  245 reports

Recent VENTRALEX adverse event reports

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

• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Abscess; Hernia; Pain

  MAUDE report 50947223 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On b)(6) 2011 ¿ Patient was diagnosed with Multiple incarcerated ventral incisional hernias thereby underwent open repair with the implant of Ventralex Mesh (Device 1, 2). Per op notes, ¿The hernia sac was identified. Hernias were noted in inferior portion and periumbilical area. A Ventralex Mesh (Device 1) was placed in right upper quadrant using sutures. The periumbilical hernias were noted. A medium Ventralex Mesh (Device 2) was placed against the fascial edge and secured using sutures.¿ On (b)(6) 2013 ¿ Patient was diagnosed with recurrent incarcerated multiple ventral hernia, infected mesh with necrotic fasciitis, abscess thereby underwent open repair with the removal of meshes (Device 1, 2). Per op notes, ¿The larger hernia sac or two was identified. A significant chronic inflammation with necrotic fascia. The hernia sac was resected. A incarcerated hernia which was located just right and lateral to the umbilicus. The two infected mesh was identified with obvious purulent fluid were removed. A synthetic mesh was placed and secured to the defect using sutures.¿

  Patient problems: Hernia; Purulent Discharge; Unspecified Infection

  MAUDE report 50942962 ↗
• InjurySep 29, 2026Migration

  Patient problems: Adhesion(s)

  MAUDE report 50929896 ↗
• InjurySep 28, 2026Patient-Device Incompatibility

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

  MAUDE report 50918134 ↗
• InjurySep 22, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2011- Patient was diagnosed with incarcerated umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "The hernia sac with omentum was identified in umbilical region and the omentum was reduced. A Ventralex Mesh (Device 1) was placed and sutured." (b)(6) 2011 - Patient was diagnosed with incisional hernia, thereby underwent laparoscopic repair with implant of Ventralight ST Mesh (Device 2). (Note: There is no operative notes provided for this procedure).(b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia, thereby underwent laparoscopic repair with implant of Ventralight ST Using Echo PS (Device 3). Per op notes, "Some adhesions of the omentum to the abdominal wall in upper abdomen was noted. The Recurrence hernia was noted in central portion of previously placed mesh. The surface of mesh was cleared and the hernia sac was dissected. A Ventralight ST Using Echo PS (Device 3) was placed in the abdomen and was sutured." (The previously placed mesh mentioned in the procedure was unknown).

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50850437 ↗
• InjurySep 21, 2026Patient-Device Incompatibility

  Patient problems: Hernia

  MAUDE report 50837858 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2011 - Patient was diagnosed with epigastric hernia and umbilical hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1 and 2). Per op notes, "A small incision was made in the epigastrium region and dissected down on the large hernia sac. The hernia sac was freed up and excised. A large Ventralex Mesh (Device 1) was placed and secured through both the superior and inferior areas with suture. A keyhole incision was made to the right of the umbilicus around the umbilicus. The hernia sac was identified and amputated. The hernia sac was closed with suture, reduced the hernia sac and developed a preperitoneal plane. A medium Ventralex Mesh (Device 2) was placed in this preperitoneal space and secured with suture." (b)(6) 2015 - Patient was diagnosed with recurrent incisional hernia thereby underwent laparoscopic repair with implant of Composix L/P Mesh (Device 3). Per op notes, "Multiple Swiss cheese defects extending the length of the midline abdominal incision was made. Omental adhesions were to the anterior abdominal wall were taken down. The defect was measured and a Composix L/P Mesh (Device 3) was placed to cover the defect a

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

  MAUDE report 50801945 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  As reported, following implantation of Ventralex ST Mesh, the patient developed an infection and subsequently underwent mesh explantation.

  Patient problems: Unspecified Infection

  MAUDE report 50593015 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2014- Patient was diagnosed with recurrent incarcerated ventral hernia thereby underwent open repair with implant of Ventrio ST Mesh (Device 1). Per op notes, "Through upper midline incision in umbilical region, multiple smaller defects with incarcerated hernias were reduced. A Ventrio ST Mesh (Device 1) was placed covering all the hernia defects and sutured." (b)(6)2014- Patient was diagnosed with small bowel obstruction, thereby underwent open repair. Per op notes, "Through the incision in umbilical region, lower midline fascia in midline was divided. Dense adhesions with the Ventrio ST Mesh (Device 1) was noted and was adhesions were lysed. Lower few portion of the Ventrio ST Mesh (Device 1) was cut and the omentum was reduced. The midline fascia was then closed with sutures." (b)(6)2014- Patient was diagnosed with recurrent incarcerated incisional hernia, thereby underwent laparoscopic repair with implant of Ventralex ST Meshes (Device 2 and 3). Per op notes, "Two hernia defects, one at the corner of the prior mesh (Device 1) and the second hernia at the right lower edge of the mesh (Device 1). Extensive adhesiolysis was performed. A hernia sac in

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50582080 ↗
• InjurySep 1, 2026Patient-Device Incompatibility

  Patient problems: Abdominal Pain; Adhesion(s); Bowel Perforation; Obstruction/Occlusion

  MAUDE report 50541554 ↗
• InjurySep 1, 2026Patient-Device Incompatibility

  Per Information provided:(b)(6) 2008 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with implant of Ventralex Mesh (Device 1). Per op notes, "An incision was made in the previous scar. The hernia sac was encountered and was dissected away from the surrounding tissue. A Ventralex Mesh (Device 1) was placed into the peritoneal cavity using sutures.¿ (b)(6) 2008 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of Ventralex Mesh (Device 1) and implant of synthetic mesh. Per op notes, ¿An incision was made in the previous scar and extended down to the subcutaneous tissue. The Ventralex Mesh (Device1) was well incorporated and densely adherent to the fascia.The previous Ventralex Mesh (Device 1) was excised. Two synthetic meshes were placed at inner and outer layer and were secured with sutures.¿(b)(6) 2009 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with explant of synthetic mesh and implant of Bard Flat Mesh (Device 2). Per op notes, ¿The synthetic meshes along with the tacks were removed. A Bard Flat Mesh (Device 2) was placed on the undersurface of the fascia u

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50540247 ↗
• InjuryAug 26, 2026Migration

  Per information provided:(b)(6) 2012 - Patient was diagnosed with ventral hernia thereby underwent open repair with the implant of Ventralex ST mesh (Device 1). Per op notes, "An infraumbilical incision was made. The medium Ventralex ST mesh (Device 1) was placed into the abdominal cavity using sutures."(b)(6) 2013 - Patient was diagnosed with recurrent ventral hernia thereby underwent open repair with the implant of Ventralex ST mesh (Device 2). Per op notes, "An incision was made over the hernia in the supraumbilical area. A hernia sac was dissected out, a mediumVentralex ST mesh (Device 2) was placed into the abdominal cavity using sutures." (b)(6) 2018 - Patient was diagnosed with incisional hernia thereby underwent repair with the removal of old mesh (Device 1 and 2). Per op notes, "A Supraumbilical incision was made to expose the hernia sac in the disrupted previously paced mesh. The mesh (Device 1 and 2) were removed, then a synthetic mesh was placed."

  Patient problems: Hernia

  MAUDE report 50458139 ↗
• InjuryAug 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2016 ¿ Patient was diagnosed with left upper quadrant trocar site incisional hernia, umbilical hernia thereby underwent laparoscopic repair with the implant of Ventralex ST Meshes (Device 1, 2). Per op notes, ¿The hernia defect was noted in left upper quadrant. A Ventralex ST mesh (Device 1) was placed and laid against anterior abdominal wall using sutures. Attention to the umbilical hernia, A large Ventralex ST Mesh (Device 2) was placed against the hernia defect using sutures.¿ (b)(6) 2016 ¿ Patient had adhesions thereby underwent open repair with the lysis of adhesion. Per op notes, ¿Adhesion to the mesh (Device 2) in umbilicus was lysed. The mesh was divided.¿ (b)(6) 2016 ¿ Patient was diagnosed with nonhealing midline abdominal wound thereby underwent open repair. Per op notes, ¿The fluid filled at the superior aspect of wound. The pus was drained. Nonviable tissues were debrided.¿ (b)(6) 2017 ¿ Patient had chronic drainage and was diagnosed with non healing surgical wound, mesh infection thereby underwent open repair with the removal of mesh. Per op notes, ¿The chronic drainage was noted. All the mesh was excised. Due to incorporation of mesh,

  Patient problems: Impaired Healing; Seroma; Unspecified Infection

  MAUDE report 50436342 ↗
• InjuryAug 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2006 - Patient was diagnosed with incisional hernia thereby underwent open repair with implant of Bard Flat Mesh (Device 1). Per op notes, ¿The upper skin incision was made. A hernia defect was identified and opened. There was small bowel in close contact with the hernia sac was taken down. Multiple small defects most of them in upper incision were noted and connected. A Bard Flat Mesh (Device 1) was placed and sutured.¿ (b)(6) 2011 - Patient was diagnosed with incarcerated ventral hernia thereby underwent laparoscopic converted to open repair with. Per op notes, ¿Adhesions were taken down. Some omentum adherent to abdominal wall were taken down. The hernia was noted in the upper midline. Midline incision was opened. The hernia sac adherent to small bowel were taken down. Adhesions to the margins of old mesh (Device 1) were taken down. The defect was repaired with sutures and staples.¿ (b)(6) 2011 - Patient was diagnosed with recurrent incisional hernia thereby underwent open repair with partial excision of Bard Flat Mesh (Device 1) and implant of synthetic mesh. Per op notes, ¿Staples were removed. The hernia sac was opened and contained bowel were

  Patient problems: Adhesion(s); Hernia; Unspecified Infection

  MAUDE report 50434986 ↗
• InjuryJul 28, 2026Material Deformation

  Per information provided:(b)(6) 2008- Patient was diagnosed with two incisional hernias thereby underwent open repair with implant of Ventralex Mesh (Device 1 and Device 2). Per op notes, "An incision was made through the left lateral scar, approximately two- third of the way between the umbilicus and pubis. Some areas of fat necrosis and a large defect with a loop of bowel adherent to a hernia sac were identified. The bowel was taken down. A Ventralex Mesh (Device 1) was placed in the wound and the wound was partially closed over the mesh and was secured with tacks to the fascia. The umbilicus was opened and below which another transverse incision was made. A large omental fat from the small defect at the base of the umbilicus was identified, the fat was reduced and a Ventralex Mesh (Device 2) was placed and was secured with tacks."(b)(6) 2015- Patient was diagnosed with abdominal pain and incisional hernia, adhesion, obstruction thereby underwent open repair with excision of Ventralex Mesh (Device 1 and Device 2) and implant of XenMatrix graft (Device 3). Per op notes, "A sterile incision was made above the umbilicus down to the pubis. The large amount of calcified mesh that was

  Patient problems: Abdominal Pain; Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 50052060 ↗

Other Davol Inc. products

• PerFix16 models · 1,718 reports
• BARD25 models · 1,538 reports
• VENTRALIGHT28 models · 1,284 reports · 2 recalls
• 3DMAX18 models · 1,067 reports
• VENTRIO18 models · 756 reports
• COMPOSIX18 models · 510 reports
• Hydro-Surg8 models · 307 reports · 2 recalls
• OPTIFIX5 models · 367 reports