Phasix 1203035Recalls & reported problems
Davol Inc. · Phasix ST Mesh, 30 cm x 35 cm (12" x 14"), Rectangle · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 00801741095382), received between Jan 29, 2019 and Jan 29, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
Patient problems
- Abscess1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
THE FOLLOWING WAS REPORTED. ON (B)(6) 2018 - THE PATIENT UNDERWENT THE "REPAIR OF 6 VARIOUS VENTRAL HERNIAS RANGING FROM INCISION AT THE MIDLINE TO LATERAL ON BOTH LEFT AND RIGHT SIDE. SURGEON DISSECTED INDIVIDUAL LAYERS OF ABDOMINAL WALL, INCLUDING TRANSVERSUS ABDOMINAL RELEASE IN ORDER TO CLOSE ALL DEFECTS. THE PATIENTS POSTERIOR RECTUS SHEATH WAS EXTREMELY WEAK AND CONTINUED TO TEAR AS DEFECTS WERE CLOSED UNDER VERY LITTLE TENSION. DECISION WAS MADE TO USE BARD PHASIX ST (DEVICE #1) INTRA-ABDOMINALLY TO PROTECT THE VISCERA AND PROVIDE STRUCTURE FOR POSTERIOR RECTUS SHEATH TO REMODEL. ADDITIONALLY, THE SURGEON FELT AS THOUGH SHE WANTED TO ADD ANOTHER LAYER OF PERMANENT MESH, BARD SOFT MESH (DEVICE #2) WAS USED IN THE RETRO RECTUS SPACE TO ENSURE THAT THE HERNIAS WOULD NOT RETURN. ALL LAYERS OF THE ABDOMINAL WALL WERE CLOSED AND DRAINS WERE PLACED." "AFTER REPAIRING THE HERNIAS, PLACING THE MESH AND CLOSING THE ABDOMEN, THE SURGEON CONTINUED TO PERFORM A PANNICULECTOMY." THE PANNICULECTOMY CONTRIBUTED TO CASE BEING ALMOST 6 HOURS LONG. ON (B)(6) 2019 - THE PATIENT WAS ADMITTED DUE TO POSTOPERATIVE INTRA-ABDOMINAL ABSCESS AND INFECTION AND IS CURRENTLY UNDERGOING ANTIBIOTIC THERAPY
Patient problems: Abscess; Unspecified Infection
MAUDE report 8286304 ↗
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- GalaFORM 3D 100043-02Tepha, Inc. · Surgical Film41 reports
- Phasix 1190500Davol Inc. · surgical film39 reports
- GalaSHAPE 3D 100042-04Tepha, Inc. · Surgical Film37 reports
- GalaFORM 3D 100043-04Tepha, Inc. · Surgical Film29 reports
- Phasix 1190400Davol Inc. · surgical film26 reports
- Phasix 1190200Davol Inc. · surgical film22 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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