DuraGen® Suturable DURS3391Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10381780023517), received between Sep 23, 2022 and Mar 30, 2023 — classified as 3 injuries.

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

• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPORTED THAT DURAGEN SUTURABLE DURAL REGENERATION TEMPLATE 3 (DURS3391) WAS USED DURING A VENTRICULAR SHUNT OF THE PATIENT AND AFTER 24 POSTOPERATIVE HOURS, THE PATIENT PRESENTED A CEREBROSPINAL FLUID (CSF) FISTULA AGAIN REQUIRING A REOPERATION OR FISTULA CLOSURE. THERE WAS A DELAY OF FEW MINUTES DUE TO PRODUCT PROBLEM. PATIENT WAS REPORTED AS STABLE.

  Patient problems: Fistula

  MAUDE report 16645739 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 4 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3003418325-2022-00019. 1121308-2022-00097. 3003418325-2022-00020. A FACILITY REPORTED THAT ON (B)(6) 2022, DURAGEN SUTURABLE + DURASEAL WAS USED IN AN UNSPECIFIED SURGERY AND ON (B)(6) 2022, THE SURGEON REQUESTED FOR RE-INTERVENTION AS PATIENT PRESENTED WITH CEREBROSPINAL FLUID (CSF) FISTULA. THEY CONSIDERED REMOVING AND CLEANING TO PLACE A NEW DURAGEN SUTURABLE + DURASEAL. THE SECOND SURGERY WAS SCHEDULED ON (B)(6) 2022 WHERE DURAGEN SUTURABLE + DURASEAL WAS USED AGAIN. ON (B)(6) 2022, THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH CSF FISTULA AGAIN AND SAID SURGEON REQUESTED RE-INTERVENTION, CONSIDERING NOT USING INTEGRA PRODUCTS. THERE WAS AN UNSPECIFIED DELAY IN SURGERY.

  Patient problems: Fistula

  MAUDE report 15474515 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS 2 OF 4 REPORTS LINKED TO MFG REPORT NUMBERS: 3003418325-2022-00019, 3003418325-2022-00020, 1121308-2022-00098. A FACILITY REPORTED THAT ON (B)(6) 2022, DURAGEN SUTURABLE + DURASEAL WAS USED IN AN UNSPECIFIED SURGERY AND ON (B)(6) 2022, THE SURGEON REQUESTED FOR RE-INTERVENTION AS PATIENT PRESENTED WITH CEREBROSPINAL FLUID (CSF) FISTULA. THEY CONSIDERED REMOVING AND CLEANING TO PLACE A NEW DURAGEN SUTURABLE + DURASEAL. THE SECOND SURGERY WAS SCHEDULED ON (B)(6) 2022 WHERE DURAGEN SUTURABLE + DURASEAL WAS USED AGAIN. ON (B)(6) 2022, THE SURGEON REPORTED THAT THE PATIENT PRESENTED WITH CSF FISTULA AGAIN AND SAID SURGEON REQUESTED RE-INTERVENTION, CONSIDERING NOT USING INTEGRA PRODUCTS. THERE WAS AN UNSPECIFIED DELAY IN SURGERY.

  Patient problems: Fistula

  MAUDE report 15474390 ↗

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