OviTex® LPR F10244-0909LRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09421904065765), received between Jan 17, 2022 and Aug 19, 2026 — classified as 5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  A patient underwent open ventral hernia repair for a 4-6cm defect with 9x9cm OviTex LPR placed preperitoneally. The patient returned approximately one week later with redness, swelling, and fluid build up. The surgeon reoperated to explant the device.

  Patient problems: Erythema; Fluid Discharge

  MAUDE report 50329015 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT HERNIA REPAIR WITH OVITEX LPR ON (B)(6) 2025. THE SURGEON SEWED THE DEVICE IN PLACE AND ALSO UTILIZED A CAPSURE TACKER (PERMANENT STAINLESS STEEL AND PEEK). THE PATIENT RETURNED SYMPTOMATIC FOR ABSCESS AND UNDERWENT EXPLORATORY LAPAROTOMY APPROXIMATELY 5 WEEKS LATER. UPON REOPERATION, IT WAS NOTED THAT ADHESIONS WERE PRESENT ALONG WITH SOME EROSION INTO THE BOWEL. THE PRODUCT AND A PORTION OF THE BOWEL WERE EXCISED.

  Patient problems: Abscess; Adhesion(s); Bowel Perforation; Erosion

  MAUDE report 21746824 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RETURNED TO THE HOSPITAL WITH ABDOMINAL PAIN ON (B)(6) 23 AFTER UMBILICAL HERNIA REPAIR WITH OVITEX LPR ORIGINALLY PERFORMED ON (B)(6) 2023. A CT SCAN SHOWED BOWEL OBSTRUCTION WHICH WAS ADDRESSED WITH SURGERY AND PARTIAL DEVICE REMOVAL. IT WAS NOTED THAT THE BOWEL WAS STUCK IN TWO PLACES REQUIRING SHARP DISSECTION AND PARTIAL BOWEL RESECTION. A BOWEL ANASTOMOSIS WAS PERFORMED AND SURGERY COMPLETED WITHOUT FURTHER REINFORCEMENT.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 17878158 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVITEX LPR DEVICE WAS USED TO REINFORCE AND REPAIR THE ABDOMINAL WALL AFTER PROSTATECTOMY IN THE INGUNAL SPACE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A SMALL BOWEL OBSTRUCTIONS AND UNDERWENT A SECONDARY SURGERY WHERE ADHESIONS TO THE DEVICE WERE FOUND AND WERE TAKEN DOWN.

  Patient problems: Adhesion(s)

  MAUDE report 13266898 ↗
• InjuryJan 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN OVITEX LPR DEVICE WAS USED TO REINFORCE AND REPAIR THE ABDOMINAL WALL AFTER PROSTATECTOMY IN THE INGUNAL SPACE. IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYMPTOMS OF A SMALL BOWEL OBSTRUCTIONS AND UNDERWENT A SECONDARY SURGERY WHERE ADHESIONS TO THE DEVICE WERE FOUND AND WERE TAKEN DOWN.

  Patient problems: Adhesion(s)

  MAUDE report 13266628 ↗