Phasix 1201325Recalls & reported problems
Davol Inc. · Phasix ST Mesh, 13 cm x 25 cm (5" x 10"), Rectangle · 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 00801741095306), received between Aug 6, 2025 and Aug 6, 2025 — 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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Purulent Discharge1
- Wound Dehiscence1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PER INFORMATION PROVIDED: (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #1). PER OPERATIVE NOTES, ¿AN INDIRECT HERNIA SAC WAS IDENTIFIED AND REMOVED AND MEDIUM PERFIX PLUG (DEVICE #1) WAS PLACED FOR THE REPAIR AND SECURED WITH SUTURES.¿ (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE #2). PER OPERATIVE NOTES, ¿A LARGE HERNIA IN THE DIRECT SPACE WAS IDENTIFIED. THE PREVIOUSLY PLACED DISLODGED SYNTHETIC MESH WAS NOTED AND REPAIRED WITH LARGE PERFIX PLUG (DEVICE #2) AND SECURED CIRCUMFERENTIALLY WITH SUTURES.¿ (B)(6) 2017 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA AND RIGHT GROIN PAIN THEREBY UNDERWENT LAPAROSCOPIC CONVERTED INTO OPEN REPAIR WITH IMPLANT OF PHASIX ST MESH (DEVICE #3). PER OPERATIVE NOTES, ¿DENSE ADHESIONS OF HERNIA MESH (DEVICE #1 AND #2) ON BOTH SIDES TO BOWEL WERE REMOVED. IN LEFT UPPER QUADRANT MIDLINE FASCIA IN THE WAS CLOSED WITH SUTURES AND PHASIX ST MESH (DEVICE #3) WAS PLACED. (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH OPEN ABDOMINAL WOUND THEREBY UNDERWENT OPEN REPAIR WI
Patient problems: Purulent Discharge; Wound Dehiscence
MAUDE report 22724946 ↗
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- Transorb TSB2020Sofradim Production · Mesh, surgical, absorbable, abdominal hernia3 reports
- Phasix 1201010Davol Inc. · Mesh, surgical, absorbable, abdominal hernia3 reports
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.