Phasix 1222530Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741163241), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Defective Device” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6) 2016: PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC REPAIR WITH IMPLANT OF 3DMAX LIGHT MESH (DEVICE #1). PER OPERATIVE NOTES, ¿THERE WAS A PIECE OF HERNIA MESH NOTED OVERLAYING THE UNDERLYING VASCULATURE AND PELVIC FLOOR. THIS WAS PEELED UP AND INDIRECT INGUINAL HERNIA WAS NOTED. THE 3DMAX LIGHT MESH (DEVICE #1) WAS PLACED IN THE ABDOMINAL CAVITY AROUND THE CORD STRUCTURES." (NOTE: THE SEEN MESH WAS UNKNOWN DURING THIS REPAIR). (B)(6) 2019: PATIENT WAS DIAGNOSED WITH MULTIPLE VENTRAL HERNIAS CAUSING AND PAIN AND DISCOMFORT THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PHASIX ST USING OPS (DEVICE #2). PER OPERATIVE NOTES, "THERE WERE MULTIPLE VENTRAL HERNIAS IDENTIFIED. SOME OF THEM HAD INCARCERATED CONTENTS WITHIN THEM. ALL THE INCARCERATED CONTENTS AND ADHESIONS WERE REDUCED. A PHASIX ST USING OPS (DEVICE #2) WAS PLACED TO UNDERSURFACE OF THE FASCIA AND SUTURED." (B)(6) 2019: PATIENT WAS DIAGNOSED WITH SMALL BOWEL OBSTRUCTION AND SMALL BOWEL ADHESIONS THEREBY UNDERWENT REMOVAL OF 3DMAX LIGHT MESH (DEVICE #1) AND PHASIX ST USING OPS (DEVICE #2). PER OPERATIVE NOTES, A SMALL POCKET OF SEROMA WAS NOTED. IDENTIFIE

  Patient problems: Adhesion(s); Obstruction/Occlusion; Seroma

  MAUDE report 21898979 ↗