Versatex VTX3030MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521532267), received between Mar 6, 2020 and Aug 11, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Mechanics Altered” (3 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 10 most recent of 10 reports, 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 ↗
• 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 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 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED IN 2021, 30 DAYS POST-OPERATIVE TO EMERGENCY LAPAROSCOPIC VENTRAL HERNIA REPAIR VIA ENHANCED-VIEW TOTALLY EXTRAPERITONEAL (ETEP) APPROACH, THERE WAS A SYMPTOMATIC SEROMA CAUSING PAIN IN THE SURGICAL SITE, WHICH NEEDED SURGICAL EVACUATION, BUT WAS COMPLETELY RESOLVED AT 1-YEAR FOLLOW-UP WITH NO SYMPTOMS AT ALL.

  Patient problems: Pain

  MAUDE report 12661865 ↗
• InjuryAug 5, 2021Adverse 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 THE IMPLANT, THE PATIENT EXPERIENCED DEHISCENCE OF MIDLINE INCISION, SEROMA, AND OPEN WOUND/POOR HEALING. POST-OPERATIVE PATIENT TREATMENT INCLUDED EXCISION OF ABDOMINAL SKIN SCAR AND WOUND SEROMA CAVITY WITH ADJACENT ISSUE REARRANGEMENT.

  Patient problems: Impaired Healing; Seroma; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 12281076 ↗
• InjuryJan 22, 2021Adverse 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED SEROMA, OPEN DRAINING WOUND, AND EXPOSED MESH. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND PARTIAL MESH REMOVAL.

  Patient problems: Fluid Discharge; Impaired Healing; Seroma; Unspecified Tissue Injury

  MAUDE report 11214431 ↗
• InjuryDec 29, 2020Adverse 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 ABDOMINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, ADHESIONS TO SMALL INTESTINE, AND SCARRING. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND MESH REMOVAL.

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

  MAUDE report 11090735 ↗
• InjuryJun 5, 2020Material Deformation; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Material Deformation; Mechanics Altered; 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 BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED CHRONIC PAIN, FAILURE OF MESH, INFLAMMATION, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, TRIPLE NEURECTOMY, AND REMOVAL OF MESH.

  Patient problems: Adhesion(s); Discomfort; Dysuria; Emotional Changes; Failure of Implant; Hernia; Inflammation; Injury; Nerve Damage; Pain; Scar Tissue; Unspecified Tissue Injury

  MAUDE report 10124682 ↗
• InjuryJun 5, 2020Adverse 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 HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED BILIOUS DRAINAGE AND ABDOMINAL PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED REMOVAL SURGERY.

  Patient problems: Abdominal Pain; Fluid Discharge; Injury

  MAUDE report 10123317 ↗
• InjuryMar 6, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Mechanics Altered; 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 ADHESIONS, SCARRING, RECURRENCE, AND PAIN. POST-OPERATIVE PATIENT TREATMENT INCLUDED MESH REMOVAL SURGERY AND ADDITIONAL IMPLANT.

  Patient problems: Abdominal Pain; Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Emotional Changes; Hematoma; Hernia; Impaired Healing; Injury; Obstruction/Occlusion; Pain; Scar Tissue; Scarring; Seroma; Unspecified Infection; Unspecified Tissue Injury

  MAUDE report 9800949 ↗