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Phasix 1193030Recalls & reported problems

Davol Inc. · Phasix Mesh, 12" x 12" (30 cm x 30 cm), Square · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741107641), received between Apr 19, 2021 and Apr 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionApr 19, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    AS REPORTED, DURING AN OPEN VENTRAL CASE WITH COMPONENT SEPARATION, A BARD/DAVOL PHASIX MESH WAS OPENED FOR USE. IT WAS REPORTED THAT UPON OPENING THE PAPER ENVELOPE A SMALL PIECE OF HAIR, OR WHAT APPEARED TO BE AN EYELASH WAS DISCOVERED DIRECTLY ON THE MESH. THE MESH WAS REMOVED FROM THE STERILE FIELD AND A NEW BARD/DAVOL PHASIX MESH WAS UTILIZED IN THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11685462 ↗

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