Versatex VTX1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521532229), received between Oct 27, 2017 and Feb 28, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE TO INGUINAL HERNIA REPAIR, THE PATIENT HAD ALLERGIC REACTION.

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

  MAUDE report 14087802 ↗
• InjuryJan 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC PROCTOPEXY, DURING THE FIRST FIRING OF THE DEVICE TO THE SACRAL BONE, THE MESH AND THE TACK WERE CAUGHT, AND THE TACK DID NOT COME OFF FROM THE DEVICE. THE MESH AND TACKER WERE TAKEN OUT OF THE BODY TOGETHER AND EXTRACTED. A SECOND TACKER WAS TAKEN OUT AND USED, HOWEVER, THE SAME PHENOMENON OCCURRED IN THE 6TH FIRING. THE TACK DID NOT COME OFF FROM THE DEVICE. IT WAS ALSO STATED THAT EVEN WHEN THE TACK AND THE HANDLE WERE DISCONNECTED, THE TACK WAS STUCK IN THE SHAFT AND COULD NOT BE USED. THE ISSUES RESULTED TO TISSUE LOSS AND TISSUE DAMAGE. THERE WAS BLEEDING/ HEMATOMA. HEMOSTASIS AND COAGULATION USING ELECTROCAUTERY WAS DONE TO REMEDIATE THE TISSUE LOSS, DAMAGE, AND BLEEDING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 13358107 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PRODUCT WAS USED FOR LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, BULGING TISSUE ON RIGHT INGUINAL, AND HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MRI ON GROIN AND DOCTOR RECOMMENDED ANOTHER SURGERY.

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

  MAUDE report 12961027 ↗
• InjuryDec 8, 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 LAPAROSCOPIC THERAPEUTIC TREATMENT OF A BILATERAL INGUINAL HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED PAIN, BULGING TISSUE ON RIGHT INGUINAL, AND HERNIA. POST-OPERATIVE PATIENT TREATMENT INCLUDED MRI ON GROIN AND DOCTOR RECOMMENDED ANOTHER SURGERY.

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

  MAUDE report 12960959 ↗
• InjuryApr 2, 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 INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED AN UNSPECIFIED ADVERSE OUTCOME. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11606719 ↗
• InjurySep 22, 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 RIGHT INGUINAL HERNIA. IT WAS REPORTED THAT AFTER THE IMPLANT, THE PATIENT EXPERIENCED RECURRENCE, BLADDER WITHIN HERNIA, ADHESIONS, AND BLADDER ISSUES. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND HERNIA REPAIR WITH NEW MESH.

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

  MAUDE report 10568653 ↗
• InjuryFeb 28, 2020Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Patient Device Interaction Problem; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; 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 RECURRENCE, MESH FAILURE, EMOTIONAL DISTRESS, AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND ADDITIONAL IMPLANT.

  Patient problems: Adhesion(s); Cramp(s) /Muscle Spasm(s); Distress; Failure of Implant; Fluid Discharge; Hernia; Injury; Pain; Perforation; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 9770918 ↗
• InjuryOct 27, 2017Torn Material; Torn Material

  ACCORDING TO THE REPORTER: DURING A TAPP PROCEDURE, THE DOCTOR TRIED TO NAIL THE PRODUCT WITH A TACKER, HOLES OF MESH EXTENDED AND THE TACKS GOT THROUGH THE MESH. A BIG HOLE ON THE CENTER WAS CREATED BY THE DOCTOR TO CHECK THE STRENGTH OF THE MESH. THE OPERATING TIME WAS EXTENDED MORE THAN 30 MINUTES. THERE WAS TISSUE DAMAGE. THERE WAS OOZING BLEEDING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT: NO PROBLEM.

  Patient problems: Blood Loss; No Code Available; Tissue Damage

  MAUDE report 6983032 ↗