VersatexRecalls & reported problems across all models

We found 10 models of Versatex by Sofradim Production in the FDA's device registry (GUDID). Together they are named in 44 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2017 and Aug 11, 2026 — classified as 1 death, 41 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

Versatex 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. Feb 23, 2018Terminated

   There have been patient reports of abdominal hernia recurrence following hernia repair. The recalling firm has added a statement to the device's Instructions for Use to make surgeons aware of risks in using the device in Transversus Abdominis Muscle Release (TAR) procedures.

   Z-1523-2018 · Root cause: Other · Recall details · FDA record ↗

Most reported Versatex problems

Versatex models

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

• Versatex VTX5050M

  Mesh, Surgical, Polymeric
  1 recall10 reports
• Versatex VTX1510

  Mesh, Surgical, Polymeric
  12 reports
• Versatex VTX3030M

  Mesh, Surgical, Polymeric
  10 reports
• Versatex VTX4530M

  Mesh, Surgical, Polymeric
  3 reports
• Versatex VTX1515X3

  Mesh, Surgical, Polymeric
  3 reports
• Versatex VTX1510X3

  Mesh, Surgical, Polymeric
  2 reports
• Versatex VTX1106

  Mesh, Surgical, Polymeric
  1 report
• Versatex VTX2020M

  Mesh, Surgical, Polymeric
  1 report
• Versatex VTX1106X3

  Mesh, Surgical, Polymeric
  1 report
• Versatex VTX1515MX3

  Mesh, Surgical, Polymeric
  1 death1 report

Recent Versatex adverse event reports

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

• InjuryAug 11, 2026Mechanics Altered; Adverse Event Without Identified Device or Use Problem

  The patient¿s attorney alleged a deficiency against the device. The product was used for a laparoscopic therapeutic treatment of a bilateral inguinal hernia. It was reported that after implant, the patient experienced abdominal pain, recurrent hernia, rectus diastasis, defective mesh, pain, suffering, emotional distress, disability, impairment, and loss of enjoyment of life. Post-operative patient treatment included resection of skin and subcutaneous tissue and mesh removal.

  Patient problems: Abdominal Pain; Distress; Emotional Changes; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 50216857 ↗
• InjuryNov 20, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATE, PAIN, RECURRENCE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.

  Patient problems: Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 23611175 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A ROBOTIC LAPAROSCOPIC INCISIONAL HERNIA REPAIR USING MESH IMPLANTED IN THE VENTRAL REGION, A HERNIA RECURRENCE OCCURRED APPROXIMATELY 12 MONTHS AFTER THE INITIAL PROCEDURE. THE RECURRENCE LED TO THE NEED FOR AN ADDITIONAL COMPLEX HERNIA REPAIR SURGERY. AN ADDITIONAL SURGERY AND HOSPITAL STAY WERE REQUIRED DUE TO THE EVENT. UPON RE-OPERATION, THERE WAS A SUSPECTED MESH FRACTURE, AS THERE WAS NO EVIDENCE OF CONNECTED MESH OVER THE CENTER OF THE DEFECT.

  Patient problems: Hernia

  MAUDE report 23288058 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, ABDOMINAL PAIN, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION AND HERNIA REPAIR WITH NEW MESH.

  Patient problems: Abdominal Pain; Discomfort; Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 22786485 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER PERFORMING THE LAPAROSCOPIC INCISIONAL HERNIA REPAIR, IT WAS IDENTIFIED THAT THE MESH USED HAD BEEN PLACED INSIDE THE ABDOMINAL CAVITY, WHICH IS NOT ITS INTENDED LOCATION. AS SUCH, A REOPERATION WAS PERFORMED ON THE SAME DAY, AND THE MESH WAS REPLACED WITH ONE INTENDED FOR ABDOMINAL CAVITY PLACEMENT. IT WAS ALSO NOTED THAT DURING THE REMOVAL OPERATION OF THE MESH, BECAUSE THE TACKER WAS DETACHED, THERE WAS SLIGHT BLEEDING DUE TO THE FIRED TACKER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 22394008 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cognitive Changes; Depression; Distress; Fistula; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; High Blood Pressure/ Hypertension; Lethargy; Memory Loss/Impairment; Nerve Damage; Neuralgia; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 22376358 ↗
• InjuryFeb 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS, RECURRENCE, ADHESIONS, PAIN, BOWEL OBSTRUCTION, DISCOMFORT, DISTRESS, EMOTIONAL HARM, DISFIGUREMENT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, HERNIA REPAIR WITH NEW MESH, DIAGNOSTIC LAPAROTOMY.

  Patient problems: Adhesion(s); Deformity/ Disfigurement; Discomfort; Distress; Emotional Changes; Hernia; Obstruction/Occlusion; Pain; Unspecified Tissue Injury

  MAUDE report 21494365 ↗
• InjuryApr 29, 2024Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH SHRINKAGE/CONTRACTION, PAIN, RECURRENCE, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED HERNIA REPAIR WITH NEW MESH, AND MEDICATION.

  Patient problems: Adhesion(s); Hernia; Pain; Unspecified Tissue Injury

  MAUDE report 19209671 ↗
• InjuryFeb 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, RECURRENCE, DIASTASIS OF THE UPPER RECTUS MUSCLE.

  Patient problems: Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Tissue Injury

  MAUDE report 18803634 ↗
• InjuryJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A VENTRAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED INFECTION, ADHESIONS, OBSTRUCTION, FISTULA, MASS, AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED WOUND VAC, BOWEL RESECTION, LYSIS OF ADHESIONS, RESECTION OF ABDOMINAL MASS, REVISION SURGERY, MESH REVISION, LAPAROTOMY, AND MESH REMOVAL.

  Patient problems: Abscess; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Fluid Discharge; Impaired Healing; Necrosis; Nodule; Obstruction/Occlusion; Unspecified Infection; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 16091463 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED ADHESIONS AND RECURRENCE. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICAL TREATMENT.

  Patient problems: Adhesion(s); Hernia; Unspecified Tissue Injury

  MAUDE report 15997614 ↗
• InjuryDec 1, 2022Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INCISIONAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED DISCOMFORT IN CENTER RIGHT SIDE OF ABDOMEN FROM BELOW RIB CAGE TO GROIN, MESH MIGRATION, SWELLING, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Adhesion(s); Discomfort; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15898844 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT¿S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, PAIN, AND NUMBNESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED MEDICATION.

  Patient problems: Hernia; Numbness; Pain; Unspecified Tissue Injury

  MAUDE report 15611782 ↗
• MalfunctionMay 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING TRANSABDOMINAL PRE-PERITONEAL INGUINAL HERNIA REPAIR, THE MESH BROKE WHEN TACKER WAS FIRED. ANOTHER MESH WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 14290972 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THERE WAS A DEFICIENCY WITH THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF AN INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED AN ALLERGIC REACTION.

  Patient problems: Burning Sensation; Discomfort; Hypersensitivity/Allergic reaction; Pain; Unspecified Tissue Injury; Urticaria

  MAUDE report 14246781 ↗

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