DuraGen® ID3301Recalls & reported problems
Integra Lifesciences Corporation · DuraGen® Dural Graft Matrix 3in x 3in, 7.5cm x 7.5cm · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780023593), received between May 5, 2025 and Jan 16, 2026 — classified as 2 injuries.
1 other recall cover devices cleared under the same FDA submission (K982180); they may or may not involve this specific model.
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
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Cerebral Edema1
- Cyst(s)1
- Paralysis1
- Purulent Discharge1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem
A FACILITY REPORTED THAT ID3301I DURAGEN 3X3 1 PACK CE WAS IMPLANTED ON AN UNKNOWN DATE, AND AFTER A MONTH, THE PATIENT SHOWED SYMPTOMS OF PARALYSIS. DIAGNOSTIC IMAGING SHOWED CYST FORMATION IN EPIDURAL AFTER THE FORMATION OF DURA MATTER. REOPERATION WAS PERFORMED, AND PUS-LIKE MATTER WAS OBSERVED ON THE REGENERATED DURA MATER WHICH WAS REMOVED COMPLETELY. BACTERIAL EXAMINATION WAS PERFORMED BUT IT WAS NEGATIVE. AFTER THE REOPERATION, THE SYMPTOMS WERE GONE, AND THE PATIENT IS ON FOLLOW-UP. THE BACTERIAL EXAMINATION IS CONTINUOUSLY PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: 1. WHAT TREATMENT AND OR MEDICATION WAS GIVEN¿ IF MEDICATIONS WERE ADMINISTERED, PLEASE INCLUDE MEDICATION NAMES. UNKNOWN 2. WHAT IS THE HEALTH HISTORY OF THE PATIENT? BRAIN TUMOR 3. PATIENT OUTCOME AND OR STATUS.: FOLLOW-UP. THE SYMPTOMS RESIDED.
Patient problems: Cyst(s); Paralysis; Purulent Discharge
MAUDE report 24094988 ↗InjuryMay 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
Recalls under the same FDA submission
These recalls involve devices cleared under K982180. One submission often covers many models, so check the product and lot details in each record.
- Z-1282-2013 · Mar 28, 2013 · TerminatedDural Graft Matrix DuraGen Dural Graft Matrix is an absorbable implant for repair of dural defects. DuraGen matrix is an easy to handle, soft, white, pliable, nonfriable, porous
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
- Durepair® 62158Medtronic Ps Medical, Inc. · DURA SUBSTITUTE1 recall0 reports
- DURAFORM 80-1477USCerenovus, Inc. · 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 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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