DuraGen® Suturable DURS2291Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780023500), received between Nov 9, 2023 and Jul 2, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K043427); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS 2 OF 2 AND LINKED TO MFG REPORT NUMBER: 3003418325-2025-00032: A FACILITY REPORTED THAT A PATIENT DIAGNOSED WITH SUBDURAL HEMATOMA UNDERWENT SURGERY ON (B)(6) 2025. HOWEVER, IN THE FOLLOWING DAYS, HE DEVELOPED A FISTULA THAT REQUIRED REOPERATION. THE REOPERATION WAS PERFORMED TO TREAT THE AFOREMENTIONED COMPLICATION. THE SAME PRODUCT REFERENCES WERE USED IN THE SECOND SURGERY, AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Fistula

  MAUDE report 22385704 ↗
• InjuryJan 31, 2025Device Handling Problem; Device Handling Problem

  N/A.

  Patient problems: Bacterial Infection

  MAUDE report 21283438 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DISTRIBUTOR INITIALLY REPORTED THE FOLLOWING: "THE PATIENT WAS INITIALLY OPERATED ON WITH A SURGICAL TECHNIQUE FOR CHIARI MALFORMATION IN WHICH THE SPECIALIST USED A CLASSIC PATCH THAT WAS IN THE INSTITUTION'S STOCK AND SUTURED IT. GIVEN THE PRESENCE OF A FISTULA, THE PATIENT MUST BE RE-OPERATED URGENTLY. FOR THIS CASE, A SUTURABLE PATCH AND A DURASEAL ARE SENT. IN THIS SECOND POSTOPERATIVE PERIOD, THE CSF LEAK PERSISTS AND A THIRD INTERVENTION IS CONTEMPLATED, WHICH IS NOT CARRIED OUT SINCE THE LEAK STOPS. IT IS NECESSARY TO CLARIFY THE INDICATIONS FOR USE OF THE DIFFERENT DURAGEN TO AVOID FUTURE ADVERSE EVENTS.". ADDITIONAL INFORMATION WAS SUBSEQUENTLY RECEIVED INDICATING THE FOLLOWING: 1. CAN YOU VERIFY THE TYPE OF PROCEDURE PERFORMED DURING THE INCIDENT? - IT WAS A RESECTION OF A CEREBELLAR TUMOR. 2. WHAT MEDICAL CHECKUP/INTERVENTION WAS PERFORMED? IF YOU HAD TO DO A REVIEW, WHAT DID YOU DO? -YES. THE DUROPLASTY WAS REVISED, A SUTURABLE PATCH AND SEALANT WERE PLACED. 3. HOW MUCH CSF WAS LEAKED DURING THE INCIDENT (IF AN EXACT AMOUNT CANNOT BE PROVIDED, PLEASE PROVIDE AN APPROXIMATE AMOUNT: SMALL, MODERATE, ETC.)? -MODERATE. 4. WAS THE PATIENT TRANSFERRED OR BEING TRANSFERRED

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19089670 ↗
• InjuryDec 7, 2023Material Puncture/Hole; Material Puncture/Hole

  N/A.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18284136 ↗
• InjuryNov 9, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  N/A

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 18108013 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043427. One submission often covers many models, so check the product and lot details in each record.

• Z-1283-2013 · Mar 28, 2013 · Terminated
  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 handl
• Z-1081-2010 · Jan 13, 2010 · Terminated
  Suturable DuraGen Dural Regeneration Matrix; Non-Pyrogenic; Sterility guaranteed unless package is damaged or opened. Rx only. Manufacturer: Integra LifeSciences Corporation, Plain