GORE BIO-A Tissue Reinforcement FS0808Recalls & reported problems
W. L. Gore & Associates, Inc. · BIO-A TISSUE REINFORCEMENT 8cmX8cm · Class 2 · Implant
All models of GORE BIO-A Tissue Reinforcement (6)
Data updated Oct 18, 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 00733132605415), received between Jan 13, 2021 and Jan 13, 2021 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Seroma1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2013 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2013, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: REMOVAL OF GORE MESH DUE TO SEROMA FORMATION AND MESH FAILURE, OPEN REPAIR OF RECURRENT INCISIONAL HERNIA DEFECT REPAIRED WITH PLACEMENT OF NEW MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Seroma
MAUDE report 11159051 ↗
Other Mesh, surgical, absorbable, abdominal hernia devices
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- Transorb TSB3030Sofradim Production · Mesh, surgical, absorbable, abdominal hernia7 reports
- Phasix 1210011Davol Inc. · Mesh, surgical, absorbable, abdominal hernia6 reports
- GORE BIO-A Tissue Reinforcement HH0710W. L. Gore & Associates, 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
- GORE BIO-A Hernia Plug HP01W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, abdominal hernia3 reports
- Transorb TSB4030Sofradim Production · Mesh, surgical, absorbable, abdominal hernia3 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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