Integra® Bovine Pericardium Dural Graft BP10405Recalls & reported problems
Integra Lifesciences Corporation · Integra® Bovine Pericardium Dural Graft is a natural, resorbable, collagenous device for use in the repair of dura mater. The device is derived from bovine pericardium and is manufactured using a multistep proprietary process which gently cleans and dehydrates the tissue. The device is terminally sterilized by gamma irradiation. The device must be sutured in place. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780074229), received between Feb 10, 2026 and Feb 10, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2026
PER SURGICAL STAFF, INTEGRA DURAFLEX PATCH USED FOR CASE BUT PATCH DISINTEGRATED CAUSING THE PATIENT TO HAVE REVISION SURGERY. INTEGRA REP KNEW ABOUT THE ISSUE AND NEVER NOTIFIED THE SURGEON OR [REDACTED]. DEVICE ID NUMBER IS 10381780511342. REF# (B)(4). SERIAL #[REDACTED].
Patient problems: Insufficient Information
MAUDE report 24303371 ↗
Other DURA SUBSTITUTE devices
- Durepair® 62100Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall6 reports
- Durepair® 62105Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall5 reports
- Durepair® 62110Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall3 reports
- DuraMatrix Onlay CDSLM45Collagen Matrix, Inc. · Dura Substitute1 recall3 reports
- Durepair® 62111Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Durepair® 62106Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall1 report
- Biodesign G31091Cook Biotech Incorporated · DURA SUBSTITUTE1 recall0 reports
- Biodesign G31091Cook Biotech Incorporated · DURA SUBSTITUTE1 recall0 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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