VENTRALEX 5950008Recalls & reported problems

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 00801741031489), received between May 23, 2017 and Sep 28, 2026 — classified as 1 death, 306 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Defective Device” (255 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 321 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Patient-Device Incompatibility

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

  MAUDE report 50918134 ↗
• InjurySep 21, 2026Patient-Device Incompatibility

  Patient problems: Hernia

  MAUDE report 50837858 ↗
• 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 ↗
• 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 ↗
• InjuryJun 30, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH INCISIONAL AND UMBILICAL HERNIAS THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OP NOTES, "A SMALL UMBILICAL HERNIA AND LARGE INCISIONAL HERNIA AT LOWER MIDLINE ABDOMEN WAS NOTED. THE LARGER MORE INFERIOR HERNIA WAS REPAIRED WITH A MEDIUM VENTRALEX ST PATCH (DEVICE 1) WAS INSERTED INTO THE PERITONEAL CAVITY WITH THE SMOOTH SURFACE POSTERIORLY AND SUPERIOR ASPECT OF PATCH EXTENDED ABOVE THE UMBILICAL HERNIA REPAIR USING SUTURES." (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL VENTRAL, AND UMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PHASIX ST MESH (DEVICE 2). PER OP NOTES, "THE OLD MESH (DEVICE 1) WAS COMPLETELY REMOVED INTACT. THERE WAS A RECURRENT HERNIA LATERAL TO THE OLD MESH. SEVERAL HERNIAS ABOVE THE UMBILICAL AREA WERE EXTENDED AND CONNECTED. A PHASIX ST MESH (DEVICE 2) WAS PLACED IN AN UNDERLAY FASHION AND SECURED CIRCUMFERENTIALLY USING SUTURES." (B)(6) 2021 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR. PER OP NOTES, ¿A SMALL PERIUMBILICAL RECURRENT INCISIONAL HERNI

  Patient problems: Hernia

  MAUDE report 25668603 ↗
• InjuryJun 29, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1). PER OPERATION NOTES, "ADHESIONS IN ABDOMINAL REGION WERE LYSED AND A VENTRAL HERNIA DEFECT WAS IDENTIFIED. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED AND TACKED." ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIA, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALEX ST MESHES (DEVICE 2 AND 3). PER OPERATION NOTES, "ONCE VENTRAL HERNIA WAS IDENTIFIED, IT WAS EXCISED. A VENTRALEX ST MESH (DEVICE 2) WAS PLACED IN ANTERIOR ABDOMINAL WALL AND TACKED. THEN A SUPRAUMBILICAL HERNIA DEFECT WAS IDENTIFIED AND REPAIRED BY PLACING A PIECE OF VENTRALEX ST MESH (DEVICE 3) AND TACKED." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH UPPER ABDOMINAL PAIN, THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATION NOTES, "EXTENSIVE ADHESIONS WITH OMENTUM STUCK TO ANTERIOR ABDOMINAL WALL WAS IDENTIFIED AND LYSED. NO EVIDENCE OF OTHER VENTRAL HERNIAS."

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 25649365 ↗
• InjuryJun 8, 2026Device Appears to Trigger Rejection

  PER INFORMATION PROVIDED: ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 1) AND VENTRIO ST MESH (DEVICE 2). PER OP NOTES, "AN UPPER MIDLINE INCISION WAS MADE. THE EPIGASTRIC VENTRAL HERNIA WAS IDENTIFIED. AN ADDITIONAL FASCIAL DEFECT CAUDAL TO THIS SITE WAS APPRECIATED FOR DEFECT. THE INCISION WAS THEN EXTENDED DISTALLY IN THE MIDLINE AND THE HERNIA SAC WAS IDENTIFIED. THE SMALL FASCIAL BRIDGE BETWEEN THE TWO DEFECTS WERE CONNECTED TO CREATE ONE LARGE DEFECT. A VENTRALEX ST MESH (DEVICE 1) WAS PLACED IN THE INTRAPERITONEAL POSITION. AN ADDITIONAL DEFECT WAS IDENTIFIED IN THE SUPRAUMBILICAL POSITION. A SEPARATE INCISION WAS MADE AT THE SITE. THE INCARCERATED FAT IDENTIFIED OF THE HERNIA SAC AND AMPUTATED AT THE LEVEL OF THE ABDOMINAL WALL FASCIA. THE DEFECT WAS REPAIRED WITH THE VENTRIO ST MESH (DEVICE 2) AND SECURED WITH SUTURES." ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH ABDOMINAL PAIN AND EVENTRATED VENTRAL HERNIA MESH THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX ST MESH (DEVICE 1) AND VENTRIO ST MESH (DEVICE 2) AND IMPLANT OF VENTRIO ST MESH (DEVICE 3). PER OP NOTES, ¿AN UPPE

  Patient problems: Abdominal Pain; Hernia

  MAUDE report 25425395 ↗
• InjuryJun 4, 2026Patient-Device Incompatibility

  AS PER ANSM USER REPORT (IN SUMMARY) (B)(4): TIME OF OCCURRENCE: 1 MONTH AFTER THE PROCEDURE. FIRST OPERATION IN (B)(6) 2020 TO REPAIR AN UMBILICAL HERNIA (SUTURE REPAIR); THE OPERATION WENT WELL, BUT 3 MONTHS LATER THE PAIN WAS STILL PERSISTENT. A CLINICAL EXAMINATION WITH THE SURGEON REVEALED A NEW HERNIA AND AN EVENTRATION. I HAD ANOTHER OPERATION IN (B)(6) 2020 WITH THE INSERTION OF A MESH (VENTRALEX ST MESH). SINCE THEN, PAIN HAS OCCURRED WHEN WALKING OR EXERTING MYSELF, ACCOMPANIED BY A BURNING SENSATION, THOUGH NOT TO THE POINT OF INCAPACITATION. I CONSULTED OTHER SURGEONS FOR A SECOND OPINION; I WAS ADVISED TO WAIT UNTIL AFTER PREGNANCY BEFORE UNDERGOING FURTHER SURGERY. IN THE MEANTIME, I HAVE BEEN RECEIVING PHYSIOTHERAPY. IN (B)(6) 2025, I UNDERWENT MY THIRD OPERATION FOR A NEW UMBILICAL HERNIA, RECTUS DIASTASIS AND ABDOMINAL WALL WEAKNESS; AS A RESULT, A NEW PROSTHESIS WAS INSERTED - THE INTRA-MESH T1 FROM THE COUSIN SURGERY GROUP. FROM THE MOMENT I LEFT THE RECOVERY ROOM, THE PAIN WAS EXCRUCIATING; I WAS UNABLE TO MOVE DESPITE REQUESTING PAINKILLERS. I RETURNED HOME IN PAIN, WHICH HAS BEEN PERSISTENT AND DEBILITATING EVER SINCE. AS PER THE OPERATING REPORT, ON (B)(6) 20

  Patient problems: Ambulation or Postural Difficulties; Pain; Paresthesia

  MAUDE report 25398184 ↗
• InjuryJun 2, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE 1 AND 2). PER OP NOTES, "INCISION WAS MADE ON THE MIDLINE OVER THE HERNIAS. TWO SEPARATE HERNIAS WERE NOTED. EACH HERNIA SACS WERE DISSECTED FREE AND RESECTED. A VENTRALEX ST (DEVICE 1 AND 2) WERE PLACED THROUGH EACH OF THESE DEFECTS AND SECURED USING PROLENE SUTURES." ON (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE 1 AND 2) AND IMPLANT OF VENTRIO MESH (DEVICE 3). PER OP NOTES, "PRIOR INCISION SITE WAS OPENED. THE HERNIA SAC WAS DISSECTED OUT. TWO LARGE HERNIA SACS WERE NOTED. THE PRIOR MESHES (DEVICE 1 AND 2) WERE BALLED UP INSIDE OF THE HERNIA. THE MESHES (DEVICE 1 AND 2) WERE DISSECTED AWAY FROM BOTH HERNIAS. THE DEFECTS WERE CONNECTED FROM THE SMALL BRIDGE BETWEEN THEM. A VENTRIO MESH (DEVICE 3) WAS PLACED AND SECURED USING SUTURES."

  Patient problems: Hernia

  MAUDE report 25365371 ↗
• InjuryMar 31, 2026Migration

  PER INFORMATION RECEIVED, ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESHES (DEVICE 1 AND 2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A MEDIUM VENTRALEX ST MESH (DEVICE 1) WAS PLACED THROUGHT THE SUPERIOR HERNIA DEFECT AND SUTURED. A LARGE VENTRALEX ST MESH (DEVICE 2) WAS THEN PLACED THROUGH THE INFERIOR HERNIA DEFECT SO IT SAT FLAT AGAINST THE ABDOMINAL WALL ON PERITONEAL SURFACE. THERE WAS AN OVERLAP OF THIS MESH (DEVICE 2) AND THE SUPERIOR MESH (DEVICE 1) AND WAS SUTURED¿. ON (B)(6) 2016- PATIENT WAS DIAGNOSED WITH ADHESIONS, THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OP NOTES, ¿THE INTRA-ABDOMINAL CONTENTS WERE ADHERENT TO THE MESH IN THE UPPER ABDOMEN. THE OMENTUM WAS ADHERENT TO THE PERITONEAL SIDE OF THE MESH IN UPPER ABDOMEN. THE ADHESIONS WERE LYSED. THE MESH (DEVICE 1 AND 2) WERE FOUND PULLED AWAY FROM ABDOMINAL WALL FROM RETRACTION. THE BORDER OF THE MESHES HAD PEELED AWAY FROM ABDOMINAL WALL WHICH IS RESUTURED¿.

  Patient problems: Adhesion(s)

  MAUDE report 24745156 ↗
• InjuryMar 4, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRIO ST MESH (DEVICE 1). PER OP NOTES, "AN INCISION TO THE LEFT ABDOMINAL SCAR, A VENTRIO ST (DEVICE 1) WAS PLACED." (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED INCISIONAL HERNIA AND ABDOMINAL WALL SEROMA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE 2). PER OP NOTES, "AN INCISION TO THE PRIOR SCAR, EXCISED THE SEROMA CAVITY. THE FASCIA WAS IDENTIFIED AROUND THE HERNIA AND UNDERLYING ADHESIONS FREED FROM FASCIA. A VENTRALEX ST MESH (DEVICE 2) WAS SECURED." (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD SOFT MESH (DEVICE 3). PER OP NOTES, "EXTENSIVE ADHESIOLYSIS TO DISSECT OMENTAL ADHESIONS FREE FROM THE ABDOMINAL WALL. THERE WAS A LARGE PIECE OF MESH WHICH HAD INCORPORATED WITH THE POSTERIOR SHEATH AND COULD NOT BE SEPARATED. A BARD SOFT MESH (DEVICE 3) AND A SYNTHETIC MESH WERE PLACED USING SUTURES."

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24511121 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (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.¿ ON (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.¿ ON (B)(6) 2015: PATIENT WAS DIAGNOSED WITH FIVE TIME RECURR

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

  MAUDE report 24331442 ↗
• InjuryFeb 5, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2006: PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX L/P MESH (DEVICE 1). PER OP NOTES, ¿THE MIDLINE HERNIA WAS IDENTIFIED AND THE OMENTAL ADHESIONS GOING UP INTO THE HERNIA WERE REDUCED. THERE WAS ONE PORTION OF OLD MESH IN THE RIGHT LOWER QUADRANT AND LEFT UNDISSECTED. A SYMPTOMATIC PORTION OF OPEN HERNIA IN UPPER MIDLINE REGION WAS IDENTIFIED. A COMPOSIX L/P MESH (DEVICE 1) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED¿. (NOTE: THE OLD MESH SEEN DURING THIS PROCEDURE WAS UNKNOWN) (B)(6) 2013: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX MESH (DEVICE 2). PER OP NOTES, ¿HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL REGION AND WAS DISSECTED. A VENTRALEX MESH (DEVICE 2) WAS PLACED IN THE PREPERITONEAL SPACE AND SUTURED¿. (B)(6) 2015: PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OP NOTES, ¿HERNIA SAC WAS IDENTIFIED IN THE ABDOMINAL CAVITY. THERE WERE ADHESIONS NOTED WITH THE EDGES OF HERNIA AND WAS LYSED. A VENTRALEX ST MESH (DEVICE

  Patient problems: Adhesion(s); Erythema; Fistula; Unspecified Infection

  MAUDE report 24267136 ↗
• 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. ADHE

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24018841 ↗
• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH EPIGASTRIC UMBILICAL HERNIA AND INFRAUMBILICAL VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF TWO VENTRALEX ST MESHES (DEVICE 1 AND 2), PER OPERATIVE NOTES, ¿A VENTRAL HERNIA IN THE EPIGASTRIC POUCH WAS FREED AND SMALL SIZED VENTRALEX ST MESH (DEVICE 1) WAS PLACED OVER THE FASCIA AND SUTURED. THE UMBILICAL HERNIA IN THE INFRAUMBILICAL AREA WAS REDUCED AND MEDIUM SIZED VENTRALEX ST MESH (DEVICE 2) WAS PLACED AND SECURED WITH SUTURES.¿ ATTORNEY ALLEGES PAIN.

  Patient problems: Pain

  MAUDE report 23614119 ↗
• InjurySep 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED ON (B)(6) 2025, VENTRALEX ST MESH WAS LAPAROSCOPICALLY INSERTED FOR A PARAUMBILICAL HERNIA REPAIR USING A CAPSURE FIXATION DEVICE. AS REPORTED THE MESH WAS DIPPED IN SALINE PRIOR TO INSERTION. IT WAS DEPLOYED THROUGH A MAIN 12MM PORT AND LIFTED TO THE DEFECT AREA USING A SUTURE PASSER. ON (B)(6) 2025, THE PATIENT SHOWED SIGNS OF BOWEL DILATION, REQUIRING ANOTHER SURGERY. DURING THIS PROCEDURE, SEVERE BOWEL ADHESIONS WERE NOTED AT THE EDGE OF THE MESH. IT WAS REPORTED THAT ADHESIONS WERE REMOVED, AND FAT OMENTUM WAS PLACED OVER TO PREVENT RECURRENCE OF ADHESION. AS REPORTED "PATIENT IS OK NOW".

  Patient problems: Adhesion(s)

  MAUDE report 23028717 ↗
• MalfunctionAug 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING SURGERY A VENTRALEX ST MESH WAS FOUND TO HAVE A TEAR WHEN DISPENSED TO THE FIELD. THE OUTER PACKAGING WAS INTACT WITH NO NOTED DAMAGE. THE MESH WAS DISCARDED; A NEW ONE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22893123 ↗
• MalfunctionAug 12, 2025Unsealed Device Packaging; Unsealed Device Packaging

  AS ALLEGED, DURING AN OPEN UMBILICAL HERNIA REPAIR ON (B)(6) 2025, WHEN THE NURSE WENT TO OPEN THE VENTRALEX ST MESH IT WAS NOTED THAT "ONE SIDE OF THE STERILE SILVER PACKAGING WAS NOT SEALED." ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786051 ↗
• InjuryAug 7, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED BY PATIENT¿S ATTORNEY AND REVIEW OF PATIENT MEDICAL RECORDS: ATTORNEY ALLEGES PER SHORT FORM THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL VENTRALEX ST ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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. (B)(6) 2015 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC CHOLECYSTITIS, ADHESIONS, UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALEX ST MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THE GALLBLADDER IS REMOVED. THE HERNIA SAC WAS EXCISED. A MEDIUM VENTRALEX ST MESH (DEVICE #1) WAS PLACED IN THE DEFECT USING SUTURES.¿ (B)(6) 2015 ¿ PATIENT HAD SEROMA AND DIAGNOSED WITH INFECTED MESH, LARGE RECURRENT UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE REMOVAL OF VENTRALEX ST MESH (DEVICE #1) AND AN IMPLANT OF XENMATRIX AB MESH (DEVICE #2). PER OPERATIVE NOTES, ¿SEROMA WAS ASPIRATED. A MINIMAL INTRAABDOMINAL ADHESION FROM OMENTUM TO THE PERIU

  Patient problems: Drug Resistant Bacterial Infection; Hernia; Seroma

  MAUDE report 22737815 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED WITH PERITONEAL FAT AND DISSECTED FREE. THE SAC AND FAT WERE REDUCED. A VENTRALEX ST (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA WITH ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #2). PER OP NOTES, ¿THE HERNIA SAC IDENTIFIED, DISSECTED FREE AND OPENED. THE HERNIA SAC WAS EXCISED. THE PREVIOUS MESH (DEVICE #1) APPEARED TO BE ROLLED UP TO THE TOP OF HERNIA RECURRENCE. THE OLD MESH WAS SUTURED BACK. A VENTRALEX ST (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6) 2018 ¿ PATIENT HAD ABDOMINAL PAIN THEREBY PROVIDED WITH MEDICATIONS. (B)(6) 2019 ¿ PATIENT HAD ABDOMINAL PAIN THEREBY UNDERWENT CT. (B)(6) 2019 ¿ PATIENT HAD ABDOMINAL PAIN PROVIDED WITH MEDICATIONS.

  Patient problems: Abdominal Pain

  MAUDE report 22724533 ↗
• InjuryJul 23, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF THE BARD COMPOSIX KUGEL MESH (DEVICE #1). PER OPERATIVE NOTES, ¿A BARD COMPOSIX KUGEL MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA, ADHESION, SCAR TISSUE THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS WERE TAKEN DOWN. A VENTRALEX ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABDOMINAL WALL ABSCESS THEREBY UNDERWENT REPAIR WITH INCISION AND DRAINAGE OF ABSCESS. ON (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH ABSCESS, ABDOMINAL WOUND, FISTULA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH EXPLANT OF BARD COMPOSIX KUGEL MESH (DEVICE #1) AND VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿ADHESIONS, ABDOMINAL WOUND, ABSCESSES WERE TAKEN DOWN. ALL PRIOR MESHES BARD COMPOSIX KUGEL MESH (DEVICE #1) AND VENTRALEX ST MESH (DEVICE #2) WERE REMOVED.¿

  Patient problems: Abscess; Adhesion(s); Fistula

  MAUDE report 22574170 ↗
• InjuryJul 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2013 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL AND INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X (DEVICE #1). PER OPERATIVE NOTES, ¿A SMALL INCISIONAL HERNIA AND UMBILICAL HERNIA CLOSE TO ONE OTHER WERE NOTED AND COMPOSIX E/X MESH (DEVICE #1) WAS PLACED IN THE ABDOMINAL CAVITY AND TACKED. THE DEFECT IN THE UMBILICUS WAS CLOSED WITH SUTURES.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL ABDOMINAL INCISIONAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH PARTIAL REMOVAL OF COMPOSIX E/X MESH (DEVICE #1) AND IMPLANT OF VENTRALEX ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS OPENED WHICH HAD A PREVIOUS HERNIA MESH (DEVICE #1) AND OMENTUM WITHIN HERNIA SAC. THE MESH (DEVICE #1) WAS EXCISED PARTIALLY AND VENTRALEX ST MESH (DEVICE #2) WAS PLACED INTO THE DEFECT AND SUTURED. ¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA, INFECTION AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF ALL MESHES (DEVICE #1 AND #2). PER OPERATIVE NOTES, ¿ADEQUATE SCAR TISSUE AND TURBID FLUID COLLECTION WERE IDENTIFIED. BOTH MESHES (DEVICE #1 AND #2) WITH SUTURES WERE IDENTI

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

  MAUDE report 22554516 ↗
• InjuryJul 17, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRALEX ST (DEVICE #1 & #2). PER OP NOTES, ¿THE HERNIA SAC WAS IDENTIFIED AND DISSECTED FREE. TWO VENTRALEX ST (DEVICE #1 & #2) WAS PLACED AND SUTURED.¿ (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH INFECTED MESH, RECURRENT VENTRAL INCISIONAL HERNIA AND POOR WOUND HEALING THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALEX ST (DEVICE #1 & #2) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿THE ADHESIONS OF MESH WERE TAKEN DOWN. THE INFECTED MESH WITH GRANULATION TISSUE WAS IDENTIFIED AND EXCISED. THE HERNIA DEFECT WAS IDENTIFIED AND EXCISED. A BIOLOGICAL MESH WAS PLACED AND SUTURED.¿ (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH SINUS GRANULOMA OF UMBILICUS AND POOR WOUND HEALING THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF GRANULOMA TISSUE. (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INFECTED SYNTHETIC MESH, RECURRENT VENTRAL INCISIONAL HERNIA AND POOR WOUND HEALING THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF RETAINED VENTRALEX ST (DEVICE #1 & #2) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿THE RETAINED INFECTED SYNTHETIC MESH (DEVIC

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

  MAUDE report 22532646 ↗