DuraGen® ID2205Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780023586), received between Nov 3, 2023 and Nov 3, 2023 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 2 OF 2 REPORTS LINKED TO MFG REPORT NUMBER 3003418325-2023-00014: A LEGAL CLAIM HAS BEEN MADE AGAINST DUREPAIR, FOR WHICH MEDTRONIC HAS REPORTING RESPONSIBILITY. CLAIM DETAILS READ AS FOLLOWS: "HIS PRODUCT WAS A CONFIRMED RECALLED LOT#. HE EXPERIENCED SEVERE COMPLICATIONS, INCLUDING FEVERS (107) SEPSIS AND POSSIBLE MENINGITIS. HE REPORTED THAT HE WAS EXTREMELY ILL, IN CRITICAL CONDITION, AND ALMOST DIED." OPERATIVE NOTES ASSOCIATED WITH THE CLAIM MADE AGAINST DUREPAIR MAKE MENTION OF DURAGEN AND DURASEAL WHICH WERE CONCOMITANTLY USED, AND READ AS FOLLOWS: EXCERPT OF OPERATIVE NOTES OF (B)(6) 2023: PREOPERATIVE DIAGNOSIS: CEREBRAL SPINAL FLUID LEAK, HYPOTHERMIA. POSTOPERATIVE DIAGNOSIS: CEREBRAL SPINAL FLUID LEAK, HYPOTHERMIA. PROCEDURE: REPAIR OF A CSF LEAK, EVACUATION OF PSEUDOMENINGOCELE, REPLACEMENT OF DURAL PATCH WITH BOVINE PERICARDIUM. ¿¿ONCE AGAIN, A SIGNIFICANT AMOUNT OF FLUID WAS NOTED IN THE TISSUES THROUGHOUT THE SURGICAL WOUND. A LARGE SAMPLE OF FLUID WAS THEN SENT TO THE MICROBIOLOGY LAB FOR SAMPLING. MAYO SCISSORS WERE USED TO CUT THE PREVIOUSLY PLACED SUTURES. A CEREBELLAR RETRACTOR WAS THEN PLACED IN THE SURGICAL WOUND TO GET GOOD EXPOSURE. THE PREVIO

  Patient problems: Cerebrospinal Fluid Leakage; Meningitis; Sepsis

  MAUDE report 18065561 ↗

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