OviTex® 1S F10246-0610PRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09421904065086), received between Jun 24, 2025 and Jan 12, 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.

• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025 THAT A PATIENT WAS EXPERIENCING POTENTIAL MESH EROSION FROM A HIATAL HERNIA REPAIR. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2025. UPON ENTERING ABDOMEN VIA ROBOTIC PORTS, THE ORIGINAL DEVICE WAS FOUND AND REMOVED FROM SUPERIOR ASPECT OF STOMACH. IT WAS REPORTED THAT THE PERMANENT SUTURE HAD ERODED INTO SUPERIOR ASPECT OF FUNDOPLICATION. THIS WAS "REMOVED EASILY", STOMACH IRRIGATED WITH SALINE AND REPAIRED WITH RESORBABLE SUTURE. THE RECURRENT HIATAL HERNIA WAS THEN REPAIRED WITH SUTURES AND PLEDGETS.

  Patient problems: Erosion

  MAUDE report 24048331 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON 11DEC2025 THAT A PATIENT WAS EXPERIENCING POTENTIAL MESH EROSION FROM A HIATAL HERNIA REPAIR. A REVISION PROCEDURE WAS CONDUCTED ON (B)(6) 2025. UPON ENTERING ABDOMEN VIA ROBOTIC PORTS, THE ORIGINAL DEVICE WAS FOUND AND REMOVED FROM SUPERIOR ASPECT OF STOMACH. IT WAS REPORTED THAT THE PERMANENT SUTURE HAD ERODED INTO SUPERIOR ASPECT OF FUNDOPLICATION. THIS WAS "REMOVED EASILY", STOMACH IRRIGATED WITH SALINE AND REPAIRED WITH RESORBABLE SUTURE. THE RECURRENT HIATAL HERNIA WAS THEN REPAIRED WITH SUTURES AND PLEDGETS.

  Patient problems: Erosion

  MAUDE report 24008981 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH OVITEX 1SP AND THE LINX REFLUX MANAGEMENT SYSTEM ON (B)(6) 2025. THE PATIENT PRESENTED WITH DYSPHAGIA AND RETURNED FOR ENDOSCOPY ON (B)(6) 2025 WHERE POTENTIAL ENTRY INTO THE ESOPHAGUS WAS NOTED. THE SURGEON NOTED THAT THEY PLAN TO PERFORM AN ADDITIONAL ENDOSCOPY TO ADDRESS THE ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 23432855 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA REPAIR WITH OVITEX 1SP AND THE LINX REFLUX MANAGEMENT SYSTEM ON (B)(6) 2025. THE PATIENT PRESENTED WITH DYSPHAGIA AND RETURNED IN (B)(6) 2025 FOR ENDOSCOPY ON (B)(6) 2025 WHERE POTENTIAL ENTRY INTO THE ESOPHAGUS WAS NOTED. THE SURGEON NOTED THAT THEY PLAN TO PERFORM AN ADDITIONAL ENDOSCOPY TO ADDRESS THE ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Erosion

  MAUDE report 23323099 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT HIATAL HERNIA SURGERY REPAIR REINFORCED WITH OVITEX 1S. APPROXIMATELY 6 MONTHS LATER, THE PATIENT UNDERWENT REOPERATION FOR SUSPECTED POTENTIAL ESOPHAGEAL EROSION. UPON REOPERATION THE SURGEON NOTED A SMALL PIECE OF POLYPROPYLENE SUTURE IN APPOSITION TO THE ESOPHAGUS. THE SUTURE WAS REMOVED WITHOUT INCIDENT AND THE PATIENT HAD NO FURTHER COMPLICATIONS. THE DEVICE WAS REPORTED TO HAVE OTHERWISE BEEN INTEGRATED AND REMODELED.

  Patient problems: Erosion

  MAUDE report 22322602 ↗