OviTex® Core F10244-1020PRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09421904065031), received between Jun 24, 2020 and Apr 13, 2023 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A HERNIA RECURRENCE APPROXIMATELY 18 MONTHS AFTER RECURRENT VENTRAL HERNIA REPAIR WITH OVITEX. UPON RE-OPERATION IT WAS NOTED THAT THE DEVICE APPEARED TO HAVE TORN AWAY FROM THE SUTURE FIXATION ON THE PERIMETER OF THE DEVICE.

  Patient problems: Hernia

  MAUDE report 16731090 ↗
• InjurySep 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15489505 ↗
• InjurySep 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15489487 ↗
• InjurySep 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADDRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15489429 ↗
• InjurySep 26, 2022No Apparent Adverse Event; No Apparent Adverse Event

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADDRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15489352 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Hernia

  MAUDE report 15481515 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADDRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Hernia

  MAUDE report 15481514 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A SURGEON REPORTED FOUR SEPARATE INDIRECT INGUINAL HERNIA RECURRENCES AFTER INGUINAL HERNIA REPAIR WITH OVITEX CORE. ALL RECURRENCES WERE ADRESSED VIA A SECOND REPAIR OPERATION. THIS IS ONE OF THESE FOUR REPORTS.

  Patient problems: Hernia

  MAUDE report 15481512 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL "REACTION" TO AN OVITEX P MESH IMPLANTED ON (B)(6) 2019. IT WAS REMOVED ON (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 10192611 ↗
• InjuryJun 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POTENTIAL "REACTION" TO AN OVITEX P MESH IMPLANTED ON (B)(6) 2019. IT WAS REMOVED ON (B)(6) 2020.

  Patient problems: Pain

  MAUDE report 10189578 ↗