DuraGen® ID4501Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780023616), received between Oct 24, 2024 and Dec 19, 2025 — classified as 3 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT AFTER IMPLANTATION OF DURAGEN 4X5 1 PACK CE (ID4501I), THE PATIENT BECAME INFECTED AND REOPERATION WAS PERFORMED ON (B)(6) 2025. RESIN WAS USED FOR CRANIOPLASTY, AND THE DOCTOR IS THINKING ABOUT REMOVING THE RESIN. PATIENT¿S INFORMATION: UNKNOWN. CURRENT STATUS: FOLLOW-UP (INFECTION HAS SUBSIDED). PRIMARY DISEASE: BRAIN TUMOR.

  Patient problems: Unspecified Infection

  MAUDE report 23849408 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT DURAGEN (ID4501I) WAS IMPLANTED TO A PATIENT WITH TETHERED SACRAL CORD SYNDROME. IT WAS USED TO PREVENT ADHESION OF NERVE AND CONNECTIVE TISSUES FROM DURA MATER. POSTOPERATIVELY, THERE WAS SUSPICION OF INFECTION AND SIGNS OF INFECTION ALL OVER THE PATIENT¿S BODY. THERE IS NO PLAN TO EXPLANT THE PRODUCT. CONSERVATIVE TREATMENT WAS GIVEN TO THE PATIENT.

  Patient problems: Unspecified Infection

  MAUDE report 22061110 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT A MONTH AFTER MENINGIOMA SURGERY, DURAGEN WAS EXPLANTED DUE TO SUSPICION OF INFECTION. LOCATION OF INFECTION IS IN THE RIGHT TEMPORAL LOBE FORNIX. AFTER TREATING THE INFECTION, THE PATIENT BECAME STABLE. MEDICATION ADMINISTERED TO THE PATIENT: MEROPENEM, VANCOMYCIN, CEFTRIAXONE.

  Patient problems: Bacterial Infection

  MAUDE report 20524037 ↗

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 · Terminated
  Dural 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