VENTRALEX 5950009Recalls & reported problems

Summary

The FDA's MAUDE database contains 378 adverse event reports that list this exact device (DI 00801741031496), received between Dec 14, 2016 and Sep 30, 2026 — classified as 2 deaths, 364 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Defective Device” (329 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 25 most recent of 378 reports, 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 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 ↗
• InjuryApr 16, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRIO MESH (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 2). PER OPERATIVE NOTES, "TWO HERNIAS, ONE SMALL LOCATED AT A PRIOR INCISIONAL SITE NEAR THE UMBILICUS AND ONE LARGER LOCATED IN UPPER PORTION OF THE ABDOMEN FROM PRIOR SURGERY, THESE BOTH WERE SIGNIFICANTLY SURROUNDED BY ADHESIONS WERE NOTED. THE ADHESIONS OF ANTERIOR ABDOMINAL WALL WERE REDUCED. THE HERNIA IN THE UPPER ABDOMEN, WAS REDUCED AND PRIMARILY REAPPROXIMATED WITH SUTURES, A VENTRIO MESH (DEVICE 1) WAS PLACED THROUGH THE ANTERIOR ABDOMINAL WALL AND SECURED WITH SUTURES. A SMALL HERNIA NEAR THE UMBILICUS WAS REDUCED, SAC AND FASCIAL DEFECT WAS CLOSED USING SUTURES. THE VENTRALEX ST MESH (DEVICE 2) WAS PLACED OVER THE DEFECT AND SECURED WITH TRANSABDOMINAL SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, "A HERNIA IN THE INFRAUMBILICAL AREA WAS NOTED. THE SAC WAS DISSECTED FREE, EXCISED. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED A

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

  MAUDE report 24902903 ↗
• InjuryApr 10, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF COMPOSIX KUGEL MESHES (DEVICE 1, DEVICE 2). PER OP NOTES, "THE FASCIAL DEFECT WAS IN THE RIGHT SIDE OF THE EPIGASTRIUM. A PRIOR MESH MATERIAL THAT HAD A LATTICE TYPE APPEARANCE WAS NOTED ADHERENT TO THE ANTERIOR ABDOMINAL WALL. A LARGE OVAL COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED INTO PERITONEAL CAVITY AND CENTERED OVER THE DEFECT USING SUTURES. THE FASCIAL TISSUE IN THE MIDLINE JUST CEPHALAD TO THE EXTENT OF THE MESH IN THE XIPHOID REGION HAS THE APPEARANCE OF DIASTASES AND SEEMS TENUOUS. AN ADDITIONAL SMALL OVAL COMPOSIX KUGEL MESH (DEVICE 2) WAS PLACED TO REINFORCE THE AREA USING TACKS." ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE 3). PER OP NOTES, "THE HERNIA SAC WAS IDENTIFIED AT SUPRAUMBILICAL AND EXTENDING OFF TO THE LEFT SIDE. THE ADHESIONS TO THE OMENTUM AND SAC WERE TAKEN DOWN. THE DEFECT WAS AT THE INFERIOR EDGE OF PREVIOUS MESH (DEVICE 1, DEVICE 2). A LARGE VENTRALEX MESH (DEVICE 3) WAS PLACED INTO ABDO

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 24845304 ↗
• InjuryApr 1, 2026Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 1). PER OP NOTES, ¿A LARGE AMOUNT OF OMENTUM STUCK INSIDE THE HERNIA WAS IDENTIFIED. ADHESIONS BETWEEN THE BOWEL, OMENTUM AND THE ABDOMINAL WALL WERE TRANSECTED. THE HERNIA CONTENTS WERE INCARCERATED AND REDUCED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED AROUND THE DEFECT WITH TACKS.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AND LEFT ABDOMINAL WALL SPIGELIAN INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC ASSISTED OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST MESH (DEVICE 1) AND IMPLANT OF VENTRALEX ST MESH (DEVICE 2) AND LAPAROSCOPIC ASSISTED REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WAS NOTED. UMBILICAL HERNIA WITH OLD MESH (DEVICE 1) WAS NOTED TO BE GONE UP INTO THE DEFECT ITSELF. THE MESH WAS MIGRATED AND DID NOT APPEAR TO BE A SIGNIFICANT OVERLAP FROM THE MESH. THE HERNIA WAS IDENTIFIED AND ALSO THE HERNIA DEFECT ON THE LEFT SIDE OF THE ABDOMEN WAS NOTED. UMBILICAL HERNIA SAC WAS

  Patient problems: Hernia

  MAUDE report 24755564 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A RECURRENT INCARCERATED UMBILICAL HERNIA WITH SAC WAS IDENTIFIED AND DISSECTED OFF. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED SUBFASCIALLY AND SUTURED IN FOUR QUADRANTS. THE FASCIA WAS CLOSED AND SECURED WITH SUTURES.¿ ON (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA AND PAIN THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿THE PRIOR MESH (DEVICE 1) WITH INFLAMMATORY TISSUES WERE EXCISED. THE RECURRENT DEFECT WAS CLOSED AND VENTRIO ST MESH (DEVICE 2) WAS PLACED OVER THE DEFECT TACKED AND SUTURED IN PLACE.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED UMBILICAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF OLD MESH (DEVICE 2) AND PRIMARY REPAIR OF INCARCERATED UMBILICAL HERNIA. PER OPERATIVE NOTES, ¿IN THE PERIUMBILICAL REGION, A PALPABLE HERNIA WITH SAC WAS NOTED. A LARGE DEFECT JUST ABOVE THE UMBILICUS AND SMALLER DEFEC

  Patient problems: Hernia; Inflammation; Pain

  MAUDE report 24377153 ↗
• InjuryFeb 18, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009- PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX KUGEL MESH (DEVICE 1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE SUPRAUMBILICAL REGION AND WAS DISSECTED. A COMPOSIX KUGEL MESH (DEVICE 1) WAS PLACED AND SUTURED¿. (B)(6) 2017- PATIENT WAS DIAGNOSED WITH RECURRENT EPIGASTRIC UMBILICAL INCISIONAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR CONVERTED TO OPEN REPAIR WITH EXPLANT OF COMPOSIX KUGEL MESH (DEVICE 1), IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OP NOTES, ¿ADHESIONS OF THE OMENTUM WITH THE MESH WAS LYSED AND THE MESH WAS EXCISED. THE HERNIA DEFECT WAS IDENTIFIED SUPERIORLY. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED AND SUTURED¿. (B)(6) 2019- PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA, PAIN, THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST MESH (DEVICE 3). PER OP NOTES, ¿ADHESIONS OF THE OMENTUM TO THE OLD MESH WAS IDENTIFIED AND THE ADHESIONS WERE LYSED. THE OMENTUM TETHERED TO THE HERNIA LOCATED BELOW THE PREVIOUSLY PLACED MESH (DEVICE 2). THE OMENTUM WAS REDUCED. THE HERNIA DEFECT WAS DISSECTED AND A VENTRALIGHT

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 24377144 ↗
• InjuryFeb 12, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH MULTIPLE INCISIONAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1, 2) AND COMPOSIX KUGEL PATCH (DEVICE 3). PER OP NOTES, ¿THE PATIENT WAS FOUND TO HAVE HERNIAS AT THE PREVIOUS ILEOSTOMY AND MUCUS FISTULA SITES. THE MEDIAN VENTRALEX ST MESH (DEVICE 1) WAS PLACED ON PREVIOUS MUCUS SITE IN THE RIGHT UPPER QUADRANT AND SECURED USING SUTURES. THE ONE IN RIGHT LOWER QUADRANT WAS REPAIRED USING A LARGE VENTRALEX ST MESH (DEVICE 2) AND SUTURED. THE MIDLINE INCISIONAL HERNIA WAS REPAIRED USING A COMPOSIX KUGEL MESH (DEVICE 3) WAS PLACED AND SECURED IN SEVERAL DIFFERENT LOCATIONS USING SUTURES.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE VENTRALEX ST MESH (DEVICE 4). PER OP NOTES, ¿IN THE PERIUMBILICAL REGION, THERE WAS A DEFINITE RECURRENT INCISIONAL HERNIA NOTED. OMENTAL ADHESIONS WERE TAKEN DOWN. THE MESH (DEVICE 1, 3) WAS SOMEWHAT BUCKLED, BUT THERE WAS NO OBVIOUS TEAR. A LARGE VENTRALEX ST MESH (DEVICE 4) WAS PLACED INTO DEFECT AND SECURED USING SUTURES.¿ (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH FIVE TIME RECURRENT IN

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

  MAUDE report 24320362 ↗
• InjuryFeb 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INTO THE ABDOMEN. THE HERNIA SAC WAS DISSECTED OUT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ ON (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, PAIN THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX ST MESH (DEVICE 1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿A PREVIOUS LOWER MIDLINE INCISION WAS REOPENED. THE HERNIA SAC WAS DISSECTED OUT. PREVIOUSLY PLACED VENTRALEX ST MESH (DEVICE 1) WAS REMOVED ENTIRELY. A SYNTHETIC MESH WAS PLACED INTO THE DEFECT AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIAS AND UMBILICAL HERNIAS, ADHESION, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 2 AND DEVICE 3). PER OPERATIVE NOTES, ¿A LOWER SKIN INCISION WAS MADE THROUGH PREVIOUS SURGICAL SCAR. THE HERNIA SAC WAS NOTED, WHICH WAS EXCISED. THERE WAS DENSE NUMBER OF ADHESIONS, WHICH WERE TAKEN DOWN. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED INTO THE PERITO

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24256491 ↗
• InjuryJan 9, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 1, 2 AND 3) AND SYNTHETIC MESH. PER OP NOTES, ¿ON THE LUQ, ADHESIONS OF ABDOMINAL WALL FROM OMENTUM AND SMALL BOWEL WERE TAKEN DOWN. THE PRIOR MESH WAS NOTED PULLED FROM THE FASCIA AND FOLDED UP WAS EXCISED. ON THE RUQ, THREE INCISIONAL HERNIA DEFECTS WERE NOTED AND DISSECTED FREE. THREE VENTRALEX ST (DEVICE 1,2 AND 3) WERE PLACED AND SUTURED. ON THE LLQ, A LARGE DEFECT WAS IDENTIFIED, AND A LARGE SYNTHETIC MESH WAS PLACED AND TACKED.¿ (NOTE: THE PRIOR MESH EXCISED IN THIS PROCEDURE WAS UNKNOWN) (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH RECURRENT MULTIPLE VENTRAL INCISIONAL HERNIAS AND BILATERAL INGUINAL HERNIAS THEREBY UNDERWENT ROBOTIC ASSISTED REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE 1,2 AND 3), SYNTHETIC MESH AND IMPLANT OF BARD SOFT MESH (DEVICE 4 AND 5). PER OP NOTES, ¿THE MIDLINE HERNIAS WERE IDENTIFIED WITH INCARCERATED OMENTUM AND BOWEL ABOVE THE UMBILICUS. THE INCARCERATED CONTENTS WERE REDUCED. ADDITIONAL HERNIAS WERE IDENTIFIED IN LLQ AND IDENTIFIED THE BILATERAL INGUINAL HERNIAS. ADHESI

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24018842 ↗
• InjuryDec 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMED PROVIDED: 08-APR-2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿A MIDLINE INCISION WAS MADE. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO ST MESH (DEVICE 1) WAS PLACED IN THE PERIFASCIAL REGION AND WAS SUTURED IN PLACED WITH SEVERAL SURGILON SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN ELLIPTICAL SKIN INCISION WAS MADE AROUND THE PREVIOUS SCAR AND UMBILICUS. THE HERNIA SAC WAS DISSECTED OUT. A VENTRIO ST MESH (DEVICE 2) WAS PLACED INTO THE DEFECT AND SECURE IT WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿LINEAR INCISION WAS MADE. THE HERNIA SAC WAS DISSECTED OUT. LYSIS OF ADHESION WAS PERFORMED. A VENTRALEX ST MESH (DEVICE 3) WAS PLACED INTO THE DEFECT AND CLOSED WITH SUTURES.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH ADHESION THEREBY UNDERWENT REPAIR WITH LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿PREVIOUSL

  Patient problems: Adhesion(s)

  MAUDE report 23775511 ↗
• InjurySep 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH SYMPTOMATIC VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿THE FASCIAL DEFECT WAS SMALL. ADHESIONS AND SAC WERE REMOVED AND SMALL SIZED VENTRALEX ST MESH WAS PLACED POSTERIOR TO FASCIA AND SECURED WITH SUTURES.¿ (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 2). PER OPERATIVE NOTES, ¿A PALPABLE REDUCIBLE UPPER MIDEPIGASTRIC SUBXIPHOID INCISIONAL HERNIA FROM TROCAR PLACEMENT FOR GALLBLADDER SURGERY WAS NOTED. A LARGE PIECE OF VENTRALEX ST MESH (DEVICE 2) WAS PLACED IN THE ABDOMINAL CAVITY TACKED AND SUTURED.¿ (B)(6) 2022 - PATIENT WAS DIAGNOSED WITH SYMPTOMATIC RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 3). PER OPERATIVE NOTES, ¿HERNIA FROM THE OLD TROCAR SCAR WAS NOTED AND SAC WAS DISSECTED. A SMALL SIZED VENTRALEX ST MESH (DEVICE 3) WAS PLACED OVER THE DEFECT AND SECURED CIRCUMFERENTIALLY WITH SUTURES.¿

  Patient problems: Hernia

  MAUDE report 23014850 ↗
• InjurySep 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR SURGERY WITH IMPLANT OF VENTRALEX ST ON (B)(6) 2015. IT WAS ALLEGED THAT THE PATIENT HAD VENTRAL HERNIA REPAIR THEREBY UNDERWENT ADDITIONAL SURGICAL INTERVENTION FOR SMALL BOWEL RESECTION AND MESH REMOVAL ON (B)(6) 2023. AS PER THE OPERATIVE REPORT ¿INDICATE THAT THE SMALL BOWEL WAS RESECTED OFF THE MESH AND THE OPEN PORTION WAS RESECTED USING A JIA STAPLER. THE SMALL BOWEL WAS THEN RE-ANASTOMOSED USING A 55MM SELECTABLE LINEAR CUTTER WITH STAPLES AND A 60MM TA STAPLER WITH DST SERIES. THE MESH WAS THEN RESECTED USING BLUNT DISSECTION WITH METZENBAUM SCISSORS.¿ ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCING INFECTIONS, RECURRENCE, CHRONIC PAIN WHICH HAVE IMPAIRED DAILY ACTIVITIES. 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 DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 22932355 ↗
• InjuryAug 11, 2025Material Deformation; Material Deformation

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT VENTRAL INCISIONAL HERNIA REPAIR SURGERY WITH IMPLANT OF VENTRALEX ST ON (B)(6) 2019. IT WAS ALLEGED THAT THE PATIENT HAD RECURRENT VENTRAL HERNIA AND THEREBY UNDERWENT WITH MESH AND REMOVAL OF FOREIGN BODY ON (B)(6) 2023, DURING THE PROCEDURE THE SURGEON NOTED THAT THE DENSE ADHESIONS, ¿THESE ADHESIONS WERE QUITE DENSE, THEY WERE MAINLY OMENTAL IN NATURE, BUT THAT THERE WAS EVIDENCE OF SOME SMALL BOWEL ATTACHMENTS AS WELL¿. PER OPERATIVE REPORT, ¿THERE WAS MESH THAT SEEMED TO BE MORE FOCUSED ON THE LEFT PART OF THE LEFT UPPER QUADRANT AREA. THIS MESH HAD SOME DENSE ATTACHMENTS THAT HAD TO BE CUT FREE COMPLETELY, BUT WE WERE ABLE TO DO THAT SAFELY UNDER DIRECT VISION, SO ALL THE BOWEL AND ADHESIONS WERE FREE. THERE WAS A PORTION OF THE MESH, HOWEVER, THAT WAS WRINKLED UP AND NOT ABLE TO LAY FLAT TO THE ABDOMINAL WALL. THIS MESH HAD TO JUST BE CUT OFF AND FREED COMPLETELY." AS ALLEGED THE PATIENT EXPERIENCED HERNIA RECURRENCE, CHRONIC PAIN WHICH HAVE IMPAIRED DAILY ACTIVITIES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERM

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 22771295 ↗
• InjuryAug 11, 2025Migration or Expulsion of Device; Patient-Device Incompatibility; Migration or Expulsion of Device; Patient-Device Incompatibility

  PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST PATCH. PER OPERATIVE NOTES, ¿AN UMBILICAL FLAP WAS RAISED SEPARATING THE HERNIA SAC FROM DERMIS. AN UNDERLAY VENTRALEX ST PATCH WAS PLACED UNDER THE FASCIA AND CLOSED USING SUTURES.¿ (B)(6) 2024 ¿ PATIENT HAD UMBILICAL CELLULITIS, INTRA-ABDOMINAL FLUID COLLECTION THEREBY UNDERWENT IR DRAINAGE OF ABDOMINAL FLUID COLLECTION. (B)(6) 2024 ¿ PATIENT HAD PAIN AND DIAGNOSED WITH INFECTED VENTRAL HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH. PER OPERATIVE NOTES, ¿THE MESH IN THE ABSCESS WAS NOT INCORPORATED WITHIN FASCIA. THE MESH WAS REMOVED IN ITS ENTIRETY ALONG WITH ABSCESS ABOVE THE INFECTED UMBILICAL SKIN. THE ADHESIONS WERE SEPARATED OUT.¿

  Patient problems: Abscess; Bacterial Infection; Cellulitis; Unspecified Infection

  MAUDE report 22769705 ↗
• InjuryAug 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH PAINFUL UMBILICAL HERNIA WITH OBSTRUCTION OR GANGRENE THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿HERNIA SAC WAS DISSECTED. A VENTRALEX MESH (DEVICE #1) WAS PLACED AND SECURE IT WITH SUTURE.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA UPPER MIDLINE, ADHESIONS THEREBY UNDERWENT OPEN REPAIR WITH LYSIS OF ADHESION AND EXPLANT OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. OLD VENTRALEX MESH (DEVICE #1) WAS COMPLETELY REMOVED. THE WOUND WAS IRRIGATED. A VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA WITH OBSTRUCTION, ADHESIONS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LYSIS OF ADHESION EXPLANT OF VENTRALEX ST MESH (DEVICE #2) AND IMPLANT ONE BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿MIDLINE ADHESIONS WERE TAKEN DOWN. OLD VENTRALEX ST MESH (DEVICE #2) WAS REMOVED. A BARD SOFT MESH (DEVICE #3) WAS PLACED AND SECURE IT WITH SUTURE.¿

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

  MAUDE report 22737044 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED. A VENTRALEX MESH (DEVICE #1) WAS PLACED OVER THE FASCIAL DEFECT AND SUTURED.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿IN THE LEFT UPPER QUADRANT, ADHERENT OMENTAL TISSUES WERE REMOVED. THE MESH (DEVICE #1) WAS SEEN DISLODGED FROM THE IMPLANT SITE. THE MESH (DEVICE #1) WAS RESECTED AND SUTURED. A LARGE VENTRALEX ST MESH (DEVICE #2) WAS PLACED OVER THE DEFECT IN THE ABDOMINAL WALL AND TACKED.¿ (B)(6) 2021 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC CONVERTED TO OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ADHESIONS WERE REMOVED. RECURRENT HERNIA DEFECT WAS NOTED AND REMOVED. THE MESH (DEVICE #2) WAS INTACT WITH TACKS. A LARGE VENTRALEX ST MESH (DEVICE #3) WAS PLACED OVER THE HERNIA DEFECT AND SUTURED AND TACKED.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22528821 ↗
• InjuryJul 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH MULTIPLE INCARCERATED INCISIONAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE #1 & #2). PER OP NOTES, ¿THE DENSE ADHESIONS OF ABDOMINAL WALL TO HERNIA SAC WERE LYSED. AFTER LYSED ALL ADHESIONS, THE INTESTINE INCARCERATED IN SAC WAS FREED. TWO COMPOSIX E/X (DEVICE #1 & #2) WERE PLACED AND TACKED. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH INTESTINAL PERFORATION AND RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF COMPOSIX (DEVICE #1 & #2) AND RESECTION OF SMALL BOWEL. PER OP NOTES, ¿THE PRIOR MESH (DEVICE #1 & #2) WAS IDENTIFIED AND REMOVED. EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. A SMALL PINHOLE PERFORATION OF THE INTESTINE WAS IDENTIFIED IN MID JEJUNUM. THAT PART OF INTESTINE WAS RESECTED. THE HERNIA DEFECT WAS REPAIRED WITH SUTURES. ¿ ON (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF COMPOSIX MESH (DEVICE #3). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND EXCISED. THE ADHESIONS WERE LYSED. A COMPOSIX MESH (DEVICE #3) WAS PLACED USING PROLENE SUTURES. ¿ (B)(6) 2010 - PATIENT WAS DIAGNO

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 22496265 ↗
• InjuryJul 9, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL AND INCISIONAL HERNIA ON SUPRAUMBILICAL, AND UMBILICAL REGION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1, #2). (NOTE: THERE IS NO OP NOTES PROVIDED FOR THIS PROCEDURE IN MEDICAL RECORDS). (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT CHRONICALLY INCARCERATED INCISIONAL HERNIA LAPAROSCOPIC REPAIR WITH THE REMOVAL OF MESHES (DEVICE #1, #2) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #3). PER OP NOTES, ¿EXTENSIVE OMENTAL ADHESIONS TO THE ANTERIOR ABDOMINAL WALL WERE NOTED. THE MESH (DEVICE #1, #2) WAS FOLDED BACK UPON ITSELF WAS DISSECTED AWAY FROM ANTERIOR ABDOMINAL WALL. A VENTRALIGHT ST MESH USING ECHO PS (DEVICE #3) WAS PLACED INTO THE HERNIA DEFECT AND SECURED USING TACKER.¿

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22455752 ↗
• InjuryJun 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE #1). PER OP NOTES, "A VENTRIO ST MESH (DEVICE #1) WAS PLACED, SUTURED AND TACKED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXPLANT OF VENTRIO ST MESH (DEVICE #1) AND IMPLANT OF VENTRIO ST MESH (DEVICE #2). PER OP NOTES, "THE MESH (DEVICE #1) WAS DISSECTED EXCEPT THE SUPERIOR PART AND REMOVED. A VENTRIO ST MESH (DEVICE #2) WAS PLACED AND SUTURED." ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH EPIGASTRIC INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE #3). PER OP NOTES, "A VENTRALEX ST MESH (DEVICE #3) WAS PLACED AND SUTURED." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL EPIGASTRIC HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF SYNTHETIC MESH. PER OP NOTES, "OMENTAL ADHESIONS IDENTIFIED TO THE PREVIOUS MESH (DEVICE #3) WERE REDUCED AND A SYNTHETIC MESH WAS PLACED AND TACKED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22327630 ↗
• InjuryJun 24, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE #1). PER OP NOTES, "A VENTRALEX MESH (DEVICE #1) WAS PLACED AND SUTURED." (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF VENTRALEX MESH (DEVICE #1) AND IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OP NOTES, "MULTIPLE ADHESIONS WERE FREED FROM THE OLD MESH (DEVICE #1). THE OLD MESH (DEVICE #1) WAS REMOVED, AND A VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SUTURED." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH PARTIAL EXPLANT OF VENTRALEX ST MESH (DEVICE #2) AND IMPLANT OF VENTRALIGHT ST USING ECHO PS (DEVICE #3). PER OP NOTES, "EXTENSIVE LYSIS OF ADHESIONS WAS PERFORMED. THE MESH (DEVICE #2) WAS EXCISED ALONG WITH TISSUE AND SOME MESH PORTIONS WERE LEFT IN PLACE. A VENTRALIGHT ST USING ECHO PS (DEVICE #3) WAS PLACED AND TACKED."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22313254 ↗
• InjuryJun 4, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA X2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1 & #2). PER OPERATIVE NOTES, ¿THE FIRST HERNIA DEFECT WAS IDENTIFIED AND REDUCED. A LARGE VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED. THE 2ND INFERIOR DEFECT WAS IDENTIFIED AND REPAIRED WITH MEDIUM SIZED VENTRALEX ST (DEVICE #2)". (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH GASTRIC OUTLET OBSTRUCTION WITH STRICTURE OF GASTRODUODENAL THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE ADHESIONS OF OMENTUM AND BOWEL WITH MESH WERE LYSED. THE BALLED UP LARGE VENTRALEX ST (DEVICE #1) WAS REMOVED AND STRICTUROPLASTY WAS PERFORMED. (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH CHRONIC WOUND DRAINAGE AND INFECTION THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL EXCISION OF MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE CHRONIC SINUS TRACT WAS REMOVED. THE MESH (DEVICE #2) WITH PURULENCE WAS PARTIALLY REMOVED. (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA X2 THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #3 & #4). PER OPERATIVE NOTES, ¿THE SMALL HERNIA DEFECT WAS ID

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 22139603 ↗
• InjuryMay 5, 2025Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem; Device Appears to Trigger Rejection; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: ON (B)(6) 2014: PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #1). PER OPERATIVE NOTES, ¿A VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST (DEVICE #2). PER OPERATIVE NOTES, ¿A VENTRALEX ST (DEVICE #2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2016: PATIENT WAS DIAGNOSED WITH INCARCERATED INCISIONAL HERNIA; MESH INFECTION AND SMALL BOWEL PERFORATION THEREBY UNDERWENT REPAIR WITH REMOVAL OF MESH (DEVICE #1 & #2) AND RESECTION OF SMALL BOWEL. PER OPERATIVE NOTES, ¿THERE WAS NOTED TO BE AN INCARCERATED INCISIONAL HERNIA WITH INFECTED EXTRUDED MESH AND THE MESH WAS EXCISED. THE SMALL BOWEL WAS ADHERENT TO THE MESH AND LOCALLY PERFORATED AND THE SMALL BOWEL WAS RESECTED.¿

  Patient problems: Adhesion(s); Bowel Perforation; Unspecified Infection

  MAUDE report 21958833 ↗
• InjuryDec 5, 2024Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  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: Adhesion(s); Fibrosis; Hernia; Inflammation; Seroma

  MAUDE report 20852274 ↗
• MalfunctionNov 13, 2024Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, A VENTRALEX ST MESH WHICH HAD A LABELED EXPIRATION DATE OF 28-MAR-2024 WAS IMPLANTED ON (B)(6) 2024 IN THE PATIENT. THERE WAS NO PATIENT INJURY. ADDENDUM: IT WAS REPORTED THAT THE MESH WAS BOOKED FOR A CASE AND WAS OPENED DURING THE PREPARATIONS, BUT DUE TO PATIENT COMPLICATIONS THEY COULD NOT PROCEED WITH PLACING THE MESH, THE EXPIRED MESH WAS NOT IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677472 ↗