OviTex® 1S F10246-2530PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09421904065727), received between Apr 16, 2019 and Nov 10, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

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.

• InjuryNov 10, 2025Migration; Migration

  A PATIENT UNDERWENT A DUAL ANASTOMOSIS CASE ON (B)(6) 2024, DURING WHICH ANASTOMOSES WERE PERFORMED ON THE UPPER AND LOWER COLON. AFTER THIS, A COMPLEX ABDOMINAL WALL CLOSURE WAS CONDUCTED. THE LOWER ANASTOMOSIS LEAKED AND THE PATIENT WAS READMITTED ON (B)(6) 2024. A CT IDENTIFIED ABSCESS WAS DRAINED WITH A SECOND DRAINAGE ON (B)(6) 2024. A FISTULA FORMED FROM THIS LOWER ANASTOMOSIS. INTESTINAL FAILURE TREATMENT COMMENCED ALONG WITH TOTAL PARENTERAL NUTRITION AND SURGICAL SCLEROSIS OF THE FISTULA UNTIL WELL ENOUGH FOR REPAIR OF LOWER ANASTOMOSIS FISTULA WHICH WAS SCHEDULED FOR ON (B)(6) 2025. A SKIN FISTULA PRESENTED INCLUDING THE PRESENCE OF POLYPROPYLENE SUTURE. A REOPERATION WAS CONDUCTED TO REMOVE A PORTION OF SUTURE MATERIAL WITH THE ABDOMINAL WALL REPAIR NOTED TO BE INTACT.

  Patient problems: Fistula

  MAUDE report 23511899 ↗
• InjuryOct 31, 2025Migration; Migration

  A PATIENT UNDERWENT A DUAL ANASTOMOSIS CASE ON (B)(6) 2024, DURING WHICH ANASTOMOSES WERE PERFORMED ON THE UPPER AND LOWER COLON. AFTER THIS, A COMPLEX ABDOMINAL WALL CLOSURE WAS CONDUCTED. THE LOWER ANASTOMOSIS LEAKED AND THE PATIENT WAS RE-ADMITTED ON (B)(6) 2024. A CT IDENTIFIED ABSCESS WAS DRAINED WITH A SECOND DRAINAGE ON (B)(6) 2024. A FISTULA FORMED FROM THIS LOWER ANASTOMOSIS. INTESTINAL FAILURE TREATMENT COMMENCED ALONG WITH TOTAL PARENTERAL NUTRITION AND SURGICAL SCLEROSIS OF THE FISTULA UNTIL WELL ENOUGH FOR REPAIR OF LOWER ANASTOMOSIS FISTULA WHICH WAS SCHEDULED FOR (B)(6) 2025. A SKIN FISTULA PRESENTED INCLUDING THE PRESENCE OF POLYPROPYLENE SUTURE. A REOPERATION WAS CONDUCTED TO REMOVE A PORTION OF SUTURE MATERIAL WITH THE ABDOMINAL WALL REPAIR NOTED TO BE INTACT.

  Patient problems: Fistula

  MAUDE report 23437828 ↗
• InjuryMay 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A COMPLEX BRIDGED ROBOTIC VENTRAL IPOM (INTRAPERITONEAL ONLAY MESH) HERNIA REPAIR WITH OVITEX 1S PERMANENT ON APPROXIMATELY (B)(6) 2024. THE PATIENT RETURNED WITH ADHESIONS AND A BOWEL OBSTRUCTION ON APPROXIMATELY (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 19367296 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT A COMPLEX BRIDGED ROBOTIC VENTRAL IPOM (INTRAPERITONEAL ONLAY MESH) HERNIA REPAIR WITH OVITEX 1S PERMANENT ON APPROXIMATELY ON (B)(6) 2024. THE PATIENT RETURNED WITH ADHESIONS AND A BOWEL OBSTRUCTION ON APPROXIMATELY ON (B)(6) 2024 AND THE DEVICE WAS EXPLANTED.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 19353852 ↗
• InjuryApr 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT WITH A HISTORY THAT INCLUDES PREVIOUS HERNIA REPAIR AND MESH INFECTION WITH STAPHYLOCOCCUS UNDERWENT SURGERY FOR A TAKEDOWN OF A COLOSTOMY AND FISTULA, A COLOPROCTOSTOMY, AND REPAIR OF A RECURRENT INCISIONAL HERNIA. ON (B)(6) 2019 SURGERY INCLUDING EXTENSIVE LYSIS OF ADHESIONS, BILATERAL COMPONENT SEPARATION AND PLACEMENT OF AN INTRAPERITONEAL OVITEX 1S PERMANENT WAS PERFORMED. PATIENT DEVELOPED A HEMATOMA THAT BECAME INFECTED AND THE INFECTION EXTENDED TO THE IMPLANT. CULTURES WERE POSITIVE FOR MORGANELLA, PROTEUS, AND (B)(6). ON (B)(6) 2019, THE LAPAROTOMY WAS RE-OPENED TO WASH OUT THE WOUND. UPON OPENING THE FASCIA IT WAS NOTED THAT THE INFECTION HAD EXTENDED TO THE MESH WHICH WAS SUBSEQUENTLY REMOVED. ANTIBIOTICS WERE GIVEN, A WOUND VAC APPLIED AND REGULAR INSPECTIONS AND DEBRIDEMENT PERFORMED AS NECESSARY. AS OF (B)(6) 2019, THE PATIENT'S INFECTION APPEARED "DRAMATICALLY IMPROVED".

  Patient problems: Bacterial Infection

  MAUDE report 8518093 ↗