Phasix 1230008Recalls & reported problems
Davol Inc. · Phasix ST Umbilical Hernia Patch, 6.4 cm / 2.5", Medium · 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 00801741226571), received between Oct 22, 2025 and Oct 22, 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
- Abdominal Pain1
- Chest Pain1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
AS REPORTED, THE PATIENT WAS IMPLANTED WITH A PHASIX ST UMBILICAL HERNIA PATCH ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT FEELS LIKE THEY ARE HAVING AN ALLERGIC REACTION WITH MULTIPLE SYMPTOMS INCLUDING HIVES, SHORTNESS OF BREATH, CHEST PAIN, ABDOMINAL PAIN, BODY ACHES. AS REPORTED THE PATIENT HAS CONSULTED WITH AN ALLERGY SPECIALIST AND HER PHYSICIAN REGARDING HER SYMPTOMS AND HAS VISITED MULTIPLE HOSPITALS AND HAS BEEN HOSPITALIZED.
Patient problems: Abdominal Pain; Chest Pain; Hypersensitivity/Allergic reaction
MAUDE report 23361323 ↗
Other Mesh, surgical, absorbable, abdominal hernia devices
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- Transorb TSB3030Sofradim Production · Mesh, surgical, absorbable, abdominal hernia7 reports
- GORE BIO-A Tissue Reinforcement HH0710W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, abdominal hernia6 reports
- Phasix 1210011Davol Inc. · Mesh, surgical, absorbable, abdominal hernia6 reports
- GORE BIO-A Tissue Reinforcement FS2020W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, abdominal hernia4 reports
- Transorb TSB2020Sofradim Production · Mesh, surgical, absorbable, abdominal hernia3 reports
- Phasix 1201010Davol Inc. · Mesh, surgical, absorbable, abdominal hernia3 reports
- GORE BIO-A Hernia Plug HP01W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, abdominal hernia3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.