OviTex® LPR F10244-1218LRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09421904065796), received between May 24, 2023 and Jul 15, 2026 — classified as 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A UNITED KINGDOM BASED SURGEON THAT A PATIENT UNDERWENT A ROBOTIC PERINEAL HERNIA REPAIR ON (B)(6) 2026 WITH OVITEX LPR PLACED ON TOP OF THE BLADDER. THE PATIENT WAS DISCHARGED AT THE END OF (B)(6). THE PATIENT WAS RE-ADMITTED TO THE LOCAL HOSPITAL WITH A BOWEL OBSTRUCTION AND UNDERWENT RE-OPERATION ON (B)(6) 2026 WHERE ADHESIONS TO THE BOWEL WERE NOTED. BOWEL RESECTIONS WERE PERFORMED AS NEEDED TO ADDRESS THE ADHESIONS.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 25834235 ↗
• InjuryJul 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY A UNITED KINGDOM BASED SURGEON THAT A PATIENT UNDERWENT A ROBOTIC PERINEAL HERNIA REPAIR ON (B)(6) 2026 WITH OVITEX LPR PLACED ON TOP OF THE BLADDER. THE PATIENT WAS DISCHARGED AT THE END OF MAY. THE PATIENT WAS RE-ADMITTED TO THE LOCAL HOSPITAL WITH A BOWEL OBSTRUCTION AND UNDERWENT RE-OPERATION ON (B)(6) 2026 WHERE ADHESIONS TO THE BOWEL WERE NOTED. BOWEL RESECTIONS WERE PERFORMED AS NEEDED TO ADDRESS THE ADHESIONS.

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 25829028 ↗
• InjuryMar 21, 2024Adverse 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 14 MONTHS AFTER VENTRAL/INCISIONAL HERNIA REPAIR. THE PATIENT UNDERWENT REOPERATION TO REPAIR THE HERNIA RECURRENCE AND TO REMOVE THE ORIGINALLY IMPLANTED DEVICE.

  Patient problems: Hernia

  MAUDE report 18956630 ↗
• InjuryMar 18, 2024Adverse 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 14 MONTHS AFTER VENTRAL/INCISIONAL HERNIA REPAIR. THE PATIENT UNDERWENT REOPERATION TO REPAIR THE HERNIA RECURRENCE AND TO REMOVE THE ORIGINALLY IMPLANTED DEVICE.

  Patient problems: Hernia

  MAUDE report 18924819 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF POST OPERATIVE PAIN AFTER VENTRAL/INCISIONAL HERNIA REPAIR WITH OVITEX LPR. AFTER MEDICATION DID NOT RESOLVE THE ISSUE, AN EXPLORATORY OPERATION WAS PERFORMED. UPON REOPERATION, FLUID COLLECTION WAS NOTED; FURTHER, ADHESIONS WERE NOTED THAT WERE EASILY FREED WITH BLUNT DISSECTION. THE DEVICE WAS REMOVED AND REPLACED WITH AN ALTERNATIVE REINFORCEMENT MATERIAL.

  Patient problems: Abdominal Pain; Seroma

  MAUDE report 18412305 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF POST OPERATIVE PAIN AFTER VENTRAL/INCISIONAL HERNIA REPAIR WITH OVITEX LPR. AFTER MEDICATION DID NOT RESOLVE THE ISSUE, AN EXPLORATORY OPERATION WAS PERFORMED. UPON REOPERATION, FLUID COLLECTION WAS NOTED; FURTHER, ADHESIONS WERE NOTED THAT WERE EASILY FREED WITH BLUNT DISSECTION. THE DEVICE WAS REMOVED AND REPLACED WITH AN ALTERNATIVE REINFORCEMENT MATERIAL.

  Patient problems: Abdominal Pain; Seroma

  MAUDE report 18384533 ↗
• InjuryMay 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PERSISTENT DRAINAGE AFTER THE USE OF THE OVITEX LPR IN ROBOTIC VENTRAL HERNIA REPAIR. THE SURGEON RE-OPERATED TO ASSESS THE SURGICAL SITE. UPON SITE ASSESSMENT IT APPEARED THAT THE DEVICE HAD PARTIALLY INTEGRATED. NON-INTEGRATED PORTIONS OF THE DEVICE WERE REMOVED AND THE PATIENT WAS CLOSED.

  Patient problems: Seroma

  MAUDE report 17016133 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED PERSISTENT DRAINAGE AFTER THE USE OF OVITEX LPR IN ROBOTIC VENTRAL HERNIA REPAIR. THE SURGEON RE-OPERATED TO ASSESS THE SURGICAL SITE. UPON SITE ASSESSMENT IT APPEARED THAT THE DEVICE HAD PARTIALLY INTEGRATED. NON-INTEGRATED PORTIONS OF THE DEVICE WERE REMOVED AND THE PATIENT CLOSED.

  Patient problems: Seroma

  MAUDE report 16997010 ↗