Versatex VTX5050MRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521532298), received between Jun 19, 2017 and Aug 5, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (6 reports).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

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 problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2021Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, 2 YEARS POST OPERATIVE A VENTRAL HERNIA REPAIR, REOPERATION WAS DONE DUE TO RECURRENT VENTRAL HERNIA. CAUSED BY CENTRAL MESH FAILURE IN ORIGINALLY PLACED.

  Patient problems: Hernia

  MAUDE report 12279872 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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, ADHESIONS, MESH FRACTURE, SCARRING, AND PAIN/DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY AND ABDOMINAL WALL RECONSTRUCTION.

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

  MAUDE report 11214315 ↗
• InjuryJun 19, 2020Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  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 PAIN, RECURRENCE, MESH FAILURE, MESH FRACTURE AND ADHESIONS. POST-OPERATIVE PATIENT TREATMENT INCLUDED LYSIS OF ADHESIONS, REVISION SURGERY AND IMPLANTATION OF ADDITIONAL MESH PRODUCT.

  Patient problems: Adhesion(s); Failure of Implant; Hernia; Injury; Pain

  MAUDE report 10174546 ↗
• InjuryFeb 28, 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 AND ABSCESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.

  Patient problems: Abscess; Hernia; Injury

  MAUDE report 9768934 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE LAPAROSCOPIC ROBOTIC ASSISTED VENTRAL HERNIA REPAIR PROCEDURE, THE PATIENT HAD RECURRENT VENTRAL HERNIA ONE YEAR AFTER THE ORIGINAL REPAIR. THE MESH FAILURE WAS CONFIRMED BY CT SCAN. REOPERATION WILL BE PERFORMED TO REPAIR THE RECURRENT VENTRAL HERNIA.

  Patient problems: No Code Available

  MAUDE report 9755928 ↗
• InjuryNov 30, 2018Degraded; Material Split, Cut or Torn; Degraded; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING ABDOMINAL WALL RECONSTRUCTION, THE PATIENT SUFFERED A CENTRAL MESH FAILURE. THE SURGEON NOTED THAT THE PATIENT RETURNED TO THE OFFICE WITH A CENTRAL MESH RECURRENT HERNIA DUE TO MESH FRACTURE. THE DOCTOR REPAIRED THE DEFECT AND EXPLANTED A PORTION OF THE MESH.

  Patient problems: Hernia; No Known Impact Or Consequence To Patient; Unspecified Tissue Injury

  MAUDE report 8119944 ↗
• InjuryJul 13, 2018Fracture; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, POST-OPERATIVE A ROBOTIC LAPAROSCOPIC ABDOMINAL WALL RECONSTRUCTION PROCEDURE, A PORTION OF THE MESH ALONG WITH PATIENT TISSUE WAS EXPLANTED DURING REPAIR OF RECURRENT HERNIA. THE MESH FRACTURED WAS REPAIRED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Hernia; No Code Available; No Known Impact Or Consequence To Patient; Prolapse; Unspecified Tissue Injury

  MAUDE report 7685141 ↗
• InjuryJul 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS USED ON THE PATIENT FOR A COMPONENT SEPARATION PROCEDURE. PROCEDURE WENT AS PLANNED AND NO UNUSUAL EVENTS OCCURRED. A FEW MONTHS AFTER SURGERY PATIENT DESCRIBED SHE NOTICED A BULGE START TO FORM AND SHE WAITED A COUPLE MORE MONTHS BEFORE CALLING TO THE DR. WHEN SHE WAS BROUGHT IN, HE EXAMINED HER AND DISCOVERED A FAILURE IN THE MIDDLE OF THE MESH. SHE WAS BROUGHT BACK IN FOR SURGERY AND THE DEFECT WAS REPAIRED. PATIENT IS STABLE.

  Patient problems: No Code Available

  MAUDE report 6706434 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER THE PATIENT EXPERIENCE A RECURRENT INCISIONAL HERNIA . THE LOCATION OF THE HERNIA IS MIDLINE. THE PATIENT WILL REQUIRE REPAIR, THERE WILL BE AN ADDITIONAL OPERATION TO CORRECT THE ISSUE. THE CURRENT PATIENT STATUS IS ALIVE WITH INJURY.THE MESH IMPLANT PROCEDURE (APPROX. 9 MONTHS PREVIOUS) WAS AN OPEN REPAIR OF RECURRENT VENTRAL INCISIONAL HERNIA, ABDOMINAL WALL RECONSTRUCTION, BILATERAL POSTERIOR TRANSVERSE ABDOMINUS RELEASE AND MAYOFASCIAL MEDIAL ADVANCEMENT FLAPS. THE SIZE OF THE DEFECT WAS 30CM X 27CM. THE MESH WAS NOT CUT PRIOR TO IMPLANTATION. THE MESH WAS NOT IMPLANTED IN A CONTAMINATED FIELD. THE MESH WAS FIXATED BY SUTURE, THE WOUND WAS CLOSED BY SUTURE AFTER THE PROCEDURE.MESH TORE IN PATIENT POST OPERATION. PATIENT IS SCHEDULED FOR A REPAIR OF THIS RECURRENCE ON (B)(6) 2017. PICTURES ARE AVAILABLE AND WILL BE PROVIDED.PATIENT MEDICAL HISTORY: PREVIOUS BYPASS SURGERY, HERNIA REPAIRS, ALLERGIES FISH AND IODINE.

  Patient problems: Hernia

  MAUDE report 6694548 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  ACCORDING TO REPORTER, WHEN THE PATIENT FELL OFF AN EXAM TABLE AT ANOTHER DOCTORS OFFICE THE USER FELT A POP, RESULTING IN RECURRENCE, WHICH WAS LATER FIXED ROBOTICALLY. THE TEAR IN THE MESH WAS CLOSED WITH A SUTURE. NO MESH WAS USED DUE TO THE GALLBLADDER REMOVAL AT SAME TIME. THE MESH WAS NOT REMOVED. THE ISSUE WAS POST OPERATIVE, RESULTING IN ANOTHER REPAIR OF THE RECURRENCE. THE ORIGINAL SURGICAL PROCEDURE WAS AN OPEN REPAIR OF VENTRAL INCISIONAL HERNIA AND ABDOMINAL WALL RECONSTRUCTION AND CHOLECYSTECTOMY. THE SIZE OF THE DEFECT WAS 21M X 30CM. THE LOCATION OF THE HERNIA WAS MIDLINE. THE FIXATION SYSTEM USED WAS SUTURE. THE MESH WAS CUT PRIOR TO IMPLANTATION. THE MESH DIMENSIONS AFTER CUTTING WAS 45X40CM. THE APPEARANCE OF THE MESH WAS NORMAL.

  Patient problems: Hernia; Unspecified Tissue Injury

  MAUDE report 6649870 ↗