Phasix 1191020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741107573), received between Jan 9, 2023 and Mar 6, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN OPEN VENTRAL HERNIA REPAIR THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. POST IMPLANT THE SURGEON ADVISED THAT A MILD SEROMA WAS OBSERVED OVER A PERIOD OF 12-15 MONTHS. IT WAS REPORTED THAT THE MESH REMAINS IMPLANTED, NO MEDICAL/SURGICAL INTERVENTION NEEDED, AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Seroma

  MAUDE report 18846425 ↗
• InjuryMar 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN OPEN INGUINAL HERNIA REPAIR THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. POST IMPLANT THE SURGEON ADVISED THAT A MILD SEROMA WAS OBSERVED OVER A PERIOD OF 12-15 MONTHS. IT WAS REPORTED THAT THE MESH REMAINS IMPLANTED, NO MEDICAL/SURGICAL INTERVENTION NEEDED, AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Seroma

  MAUDE report 18846424 ↗
• InjuryMar 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN OPEN VENTRAL HERNIA REPAIR THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. POST IMPLANT THE SURGEON ADVISED THAT A MILD SEROMA WAS OBSERVED OVER A PERIOD OF 12-15 MONTHS. IT WAS REPORTED THAT THE MESH REMAINS IMPLANTED, NO MEDICAL/SURGICAL INTERVENTION NEEDED, AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Seroma

  MAUDE report 18846419 ↗
• InjuryMar 6, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN OPEN INCISIONAL HERNIA REPAIR THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. POST IMPLANT THE SURGEON ADVISED THAT A MILD SEROMA WAS OBSERVED OVER A PERIOD OF 12-15 MONTHS. IT WAS REPORTED THAT THE MESH REMAINS IMPLANTED, NO MEDICAL/SURGICAL INTERVENTION NEEDED, AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Seroma

  MAUDE report 18846418 ↗
• InjuryMar 5, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING AN OPEN VENTRAL HERNIA REPAIR THE PATIENT WAS IMPLANTED WITH A PHASIX MESH. POST IMPLANT THE SURGEON ADVISED THAT A MILD SEROMA WAS OBSERVED OVER A PERIOD OF 12-15 MONTHS. IT WAS REPORTED THAT THE MESH REMAINS IMPLANTED, NO MEDICAL/SURGICAL INTERVENTION NEEDED, AND THE PATIENT IS REPORTED TO BE IN GOOD CONDITION.

  Patient problems: Seroma

  MAUDE report 18836058 ↗
• InjuryJan 9, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD MESH (BARD FLAT MESH) ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD MESH (BARD FLAT MESH). ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Bowel Perforation; Insufficient Information; Pain; Scar Tissue; Sepsis; Unspecified Infection

  MAUDE report 16120153 ↗