Phasix 1221015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741163203), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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.

• MalfunctionFeb 25, 2025Material Separation; Material Separation

  AS REPORTED, THE PHASIX ST W/ OPS MESH WAS QUICKLY DIPPED IN SALINE PRIOR TO USE. REPORTEDLY, DURING THE LAPAROSCOPIC HERNIA REPAIR CONVERTED TO A PLANNED OPEN PROCEDURE ON (B)(6) 2025, THE SURGEON IMPLANTED THE PHASIX ST W/ OPS MESH AND FIXATED IT AROUND THE PERIMETER OF THE MESH. ONCE FIXATION WAS COMPLETE, HE LAPAROSCOPICALLY WENT TO OBSERVE THE MESH AND NOTICED SOME OF THE MESH WAS BOWING SO HE DECIDED TO ADD A FEW MORE FASTENERS. THE SURGEON FIXATED A FEW AND THEN THE PHYSICIAN ASSISTANT (PA) FIXATED A FEW BUT WHEN THE PA WAS ADDING THE EXTRA FIXATION, IT WAS NOTICED THAT THE SEPRA BARRIER WAS ¿DELAMINATED FROM THE PHASIX ST MESH, ABOUT 2 INCHES OF IT WAS HANGING FREELY.¿ THE SURGEON AND PA DECIDED TO USE A COUPLE MORE FASTENERS TO REATTACH THE SEPRA BARRIER TO THE MESH AND TO COVER THE AREAS THAT DID NOT HAVE THE SEPRA BARRIER WITH THE PATIENT¿S OMENTUM. THE SURGEON DECIDED TO LEAVE THE MESH IN PLACE AS IT WAS WELL FIXATED AND FELT IT WOULD HAVE BEEN MORE PROBLEMATIC IF HE HAD REMOVED IT AND REPLACED THE MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461207 ↗