OviTex® 1S F10246-2020PRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09421904065130), received between Sep 27, 2021 and Aug 24, 2025 — classified as 1 death, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A HERNIA REPAIR (IPOM) WITH OVITEX 1S PERMANENT IN APPROXIMATELY (B)(6) 2025. THE CASE WAS PLANNED TO BE LAPAROSCOPIC BUT WAS CONVERTED TO OPEN. ON (B)(6) 2025, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TAKEN IN FOR SURGERY. DURING THIS SURGERY, THE SURGICAL SITE APPEARED INFECTED, AND ADHESIONS WERE PRESENT. THE DEVICE WAS REMOVED AND A SMALL BOWEL RESECTION PERFORMED.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 22881649 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A HERNIA REPAIR (IPOM) WITH OVITEX 1S PERMANENT IN APPROXIMATELY (B)(6) 2025. THE CASE WAS PLANNED TO BE LAPAROSCOPIC BUT WAS CONVERTED TO OPEN. ON (B)(6) 2025, THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TAKEN IN FOR SURGERY. DURING THIS SURGERY, THE SURGICAL SITE APPEARED INFECTED AND ADHESIONS WERE PRESENT. THE DEVICE WAS REMOVED AND A SMALL BOWEL RESECTION PERFORMED.

  Patient problems: Adhesion(s); Bacterial Infection

  MAUDE report 22877982 ↗
• DeathSep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT ROBOTIC PARASTOMAL SUGARBAKER HERNIA REPAIR ON (B)(6) 2023 WITH OVITEX. ON (B)(6) 2023, THE PATIENT PRESENTED WITH NECROTIZING ENTEROCOLITIS. THE PATIENT WAS DEBRIDED MULTIPLE TIMES. THE PATIENT PASSED AWAY APPROXIMATELY ONE WEEK LATER. IT WAS REPORTED THAT THE OVITEX DEVICE WAS INTACT.

  Patient problems: Bacterial Infection; Necrosis

  MAUDE report 17814836 ↗
• InjuryJul 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2022. OVITEX 1S WAS PLACED AS AN UNDERLAY REINFORCEMENT, SUTURED WITH INTERRUPTED SUTURES AND THE FASCIA AND SKIN CLOSED. THE PATIENT RETURNED TO OFFICE PRESENTING WITH A HERNIA BULGE WHEN EXHALING. THE HERNIA PRESENTED JUST ABOVE ORIGINAL OSTOMY SITE LATERAL TO THE PATIENT UMBILICUS ON THE RIGHT ALTHOUGH CLINICIAN BELIEVED IT TO BE JUST LATERAL TO THE DEVICE PLACEMENT, WHICH WAS CONFIRMED ON CT. THE HERNIA WAS IDENTIFIED AS BULGING AT THE SITE OF DEVICE PLACEMENT. THE SURGEON REDUCED THE HERNIA AND PLACED A DIFFERENT REINFORCEMENT MATERIAL. DURING THE REPAIR SURGERY DENSE ADHESIONS WERE NOTED TO BE ATTACHED TO BOWEL REQUIRING SHARP DISSECTION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17401704 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT VENTRAL HERNIA REPAIR ON (B)(6) 2022. OVITEX 1SP WAS PLACED AS AN UNDERLAY REINFORCEMENT, SUTURED WITH INTERRUPTED SUTURES AND THE FASCIA AND SKIN CLOSED. THE PATIENT RETURNED TO OFFICE PRESENTING WITH A HERNIA BULGE WHEN EXHALING. THE HERNIA PRESENTED JUST ABOVE ORIGINAL OSTOMY SITE LATERAL TO THE PATIENT UMBILICUS ON THE RIGHT BELIEVED IT TO BE JUST LATERAL TO THE DEVICE PLACEMENT AND WAS CONFIRMED ON CT. THE HERNIA WAS IDENTIFIED AS BULGING AT THE SITE OF DEVICE PLACEMENT. THE SURGEON REDUCED THE HERNIA AND PLACED A DIFFERENT REINFORCEMENT MATERIAL. DURING THE REPAIR SURGERY DENSE ADHESIONS WERE NOTED TO BE ATTACHED TO BOWEL REQUIRING SHARP DISSECTION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17343001 ↗
• InjuryMay 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2022. THE REPAIR WAS ROBOTICALLY COMPLETED (IPOM) WITH FASCIAL CLOSURE. THE PATIENT RETURNED IN LATE (B)(6) 2023 COMPLAINING OF PAIN WITH CT SCAN CONFIRMING A HERNIA RECURRENCE. SURGERY WAS CONDUCTED ON (B)(6) 2023 TO ADDRESS THE RECURRENCE AT WHICH POINT BOWEL ADHESIONS WERE NOTED. THE SURGEON PERFORMED ADHESIOLYSIS TO SEPARATE BOWEL FROM THE REMAINING DEVICE. HERNIA REDUCTION WAS ACHIEVED AND THE HERNIA REPAIRED.

  Patient problems: Hernia

  MAUDE report 17016113 ↗
• InjuryMay 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT UNDERWENT HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2022. THE REPAIR WAS ROBOTICALLY COMPLETED (IPOM) WITH FASCIAL CLOSURE. THE PATIENT RETURNED IN LATE (B)(6) 2023 COMPLAINING OF PAIN WITH CT SCAN CONFIRMING A HERNIA RECURRENCE. SURGERY WAS CONDUCTED ON (B)(6) 2023 TO ADDRESS THE RECURRENCE AT WHICH POINT BOWEL ADHESIONS WERE NOTED. THE SURGEON PERFORMED ADHESIOLYSIS TO SEPARATE BOWEL FROM THE REMAINING DEVICE. HERNIA REDUCTION WAS ACHIEVED AND THE HERNIA REPAIRED.

  Patient problems: Hernia

  MAUDE report 16952205 ↗
• InjuryOct 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2019, A PATIENT PRESENTED WITH GENERAL MALAISE AND FEVER. SHE PRESENTED WITH AN ABDOMINAL WALL ABSCESS AND SMALL BOWEL FISTULA ON (B)(6) 2019 WITH SURGERY TO RESOLVE. A PORTION OF THE DEVICE WAS REMOVED. PART OF THE DEVICE WAS ADHERENT TO THE SMALL BOWEL AND REMAINED IN SITU.

  Patient problems: Abscess; Fever; Fistula; Malaise

  MAUDE report 12611838 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2019, A PATIENT PRESENTED WITH GENERAL MALAISE AND FEVER. SHE PRESENTED WITH AN ABDOMINAL WALL ABSCESS AND SMALL BOWEL FISTULA ON (B)(6) 2019 WITH SURGERY TO RESOLVE. A PORTION OF THE DEVICE WAS REMOVED. PART OF THE DEVICE WAS ADHERENT TO THE SMALL BOWEL AND REMAINED IN SITU.

  Patient problems: Abscess; Fistula

  MAUDE report 12533783 ↗