Phasix 1210015Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741161223), received between Aug 14, 2024 and Aug 14, 2024 — 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.

• MalfunctionAug 14, 2024Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR THE PHASIX ST MESH W/ECHO 2 WAS QUICKLY DIPPED IN SALINE PRIOR TO ROLLING IT WITH THE COATED SIDE OF THE MESH ON THE INSIDE (PER THE IFU). A GRASPER WAS USED TO INSERT THE DEVICE INTO THE 12MM TROCAR. THE IMPLANT UNRAVELED (UNROLLED) IN THE TROCAR. THE MESH WAS REMOVED, AND IT WAS NOTED THAT IT ¿FELT DIFFERENT, GELATINOUS.¿ ANOTHER PHASIX ST W/ECHO 2 WAS USED WITHOUT ANY ISSUES TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19980999 ↗