Dura Substitute

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-01-10Open, ClassifiedUnder Investigation by firm

  Cook Medical Biodesign Dural Graft, REF C-DUR-7X10, REF G31091, Sterile

  Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

• 2024-10-30Open, ClassifiedNonconforming Material/Component

  Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694

  Out of specification endotoxin levels.

• 2023-07-20Open, ClassifiedProcess change control

  Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.

  Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

• 2022-02-24TerminatedNonconforming Material/Component

  DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches (10.0cm x 12.5cm) REF: CDSLM45

  Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

• 2022-02-24TerminatedNonconforming Material/Component

  RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated as dural substitutes for the repair of dura matter. REF: DUMO10125

  Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

• 2013-11-18TerminatedPackaging change control

  Dura Guard, Dural Repair Patch with Apex Processing. For use as a dura substitute for the closure of dura mater during neurosurgery. Product Code: DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0209SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0404SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN DG0608SN

  Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because Synovis, a subsidiary of Baxter International Inc., is recalling certain shipments of VASCUGUARD and DURA-GUARD because the shipping configurations in which the 6 fluid ounce units containing a specific revision of the Instructions for Use (IFU) shipped in a divided cell shipping

• 2013-05-10TerminatedProcess control

  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 collagen matrix. DuraGen matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes..

  Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

• 2013-05-10TerminatedProcess control

  Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.

  Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

• 2013-05-10TerminatedProcess control

  DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.

  Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

• 2013-05-10TerminatedProcess control

  DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, porous collagen matrix. DuraGen XS is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes.

  Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.