Versatex VTX4530MRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521532274), received between Feb 26, 2020 and Oct 15, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

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

  ACCORDING TO THE REPORTER, 10 MONTHS AGO, ROBOT ASSISTED LAPAROSCOPY WAS PERFORMED AND THE MESH WAS PLACED TO REPAIR THE VENTRAL HERNIA. POSTOPERATIVELY, AT THE EPIGASTRIC, UMBILICAL, AND INFRAUMBILICAL PART ON A LAPAROSCOPIC ROBOT ASSISTED VENTRAL HERNIA REPAIR, THE MESH HAD A 13CM BY 27CM DEFECT. THE PATIENT HAD A RECURRENT HERNIA THROUGH THE MESH 10 MONTHS AFTER IMPLANTATION. THE PATIENT HAD TO BE HOSPITALIZED AGAIN FOR A SECOND OPERATION VIA LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH TO REPAIR THE RECURRENT HERNIA.

  Patient problems: Hernia; No Code Available

  MAUDE report 9756293 ↗