GORE BIO-A Tissue Reinforcement FS1030Recalls & reported problems
W. L. Gore & Associates, Inc. · BIO-A TISSUE REINFORCEMENT 10cmX30cm · 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 00733132605439), received between Aug 24, 2020 and Aug 24, 2020 — 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
- Obstruction/Occlusion1
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6) 2011 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2015, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: PAIN, SMALL BOWEL OBSTRUCTION, SMALL BOWEL RESECTION WITH PRIMARY STAPLED ANASTOMOSIS, ISCHEMIC BOWEL, PULMONARY EMBOLISM, EXPLORATORY LAPAROTOMY . ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Pulmonary Embolism
MAUDE report 10446091 ↗
Other Mesh, surgical, absorbable, staple line reinforcement devices
- ECHLEON ECH60REthicon Endo-Surgery, LLC · Mesh, surgical, absorbable, staple line reinforcement313 reports
- GORE BIO-A Tissue Reinforcement FS0915W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement12 reports
- NEOVEIL NV-L-015GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement5 reports
- NEOVEIL NV-M-015GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement4 reports
- NEOVEIL NV-L-05GGunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement2 reports
- GORE BIO-A Hernia Plug HP02W. L. Gore & Associates, Inc. · Mesh, surgical, absorbable, staple line reinforcement2 reports
- NEOVEIL NV-ET-M60A-2Gunze Limited · Mesh, Surgical, Absorbable, Staple Line Reinforcement1 report
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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