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Phasix 1212025Recalls & reported problems

Davol Inc. · Phasix ST Mesh with Echo 2 Positioning System, 20 cm x 25 cm (8" x 10"), Ellipse · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741161285), received between Oct 28, 2022 and Oct 28, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Device problems

  • Patient-Device Incompatibility1

Patient problems

  • Fistula1
  • Fluid Discharge1

Recent adverse event reports

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

  • InjuryOct 28, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

    AS REPORTED, DURING VENTRAL HERNIA REPAIR ON (B)(6) 2022, A PHASIX ST W/ ECHO 2 WAS USED. IT WAS REPORTED THAT 5 WEEKS POST IMPLANT THE PATIENT PRESENTED WITH A FISTULA AND DRAINAGE. AS REPORTED SURGEON ¿DOES NOT KNOW IF FISTULA IS CONNECTED TO THE MESH BUT WE KNOW THE MESH DIDN¿T CAUSE THE FISTULA.¿ AS REPORTED, DRAINAGE OF THE FISTULA IS NOT COMING FROM THE INSERTION SITE AND THERE WAS NO SURGICAL INTERVENTION SCHEDULED OR PERFORMED AT THIS TIME.

    Patient problems: Fistula; Fluid Discharge

    MAUDE report 15690035 ↗

Other Mesh, surgical, deployer devices

All Mesh, surgical, deployer devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.