CraniSeal Dural Sealant CS-2055Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00860010683705), received between May 13, 2025 and Aug 27, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Microbial Contamination of Device

  On (b)(6)2026, dose audit samples were irradiated for a routine dose audit, with sterility testing beginning (b)(6)2026 at (b)(6) . By Day 7, 5 of the 10 samples exhibited growth and the final 5 samples were inadvertently discarded before the full 14-day incubation period was completed which rendered the sterility test invalid. Samples from the same lote were retested and confirmed to pass sterility testing. Root cause of the failure has not yet been fully determined and the investigation is still on-going. No events have been reported related to patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50484241 ↗
• MalfunctionMar 31, 2026Lack of Effect

  SUBJECT WAS SEEN BY DR. (B)(6) ON (B)(6) 2026 WITH COMPLAINTS OF SWELLING ACROSS HIS SURGICAL INCISION SITE THAT STARTED THREE DAYS PRIOR. REPORTS LOCALIZED TENDERNESS AND DENIES FEVER. REPORTS THAT SINCE SURGERY HE EXPERIENCES HEAD PRESSURE AND COGNITIVE FOGGINESS. SUBJECT WAS SENT FOR CT IMAGING ON (B)(6) 2026, THAT CONFIRMED CSF LEAK. SUBJECT DENIES ANY ACTIVITIES THAT INCREASE INTRACRANIAL PRESSURE. SUBJECT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2026. REPAIR SURGERY PERFORMED ON (B)(6) 2026. SEVERAL VALSALVA MANEUVERS WERE CONDUCTED TO FIND THE LEAK, BUT NONE WAS NOTED. WATERTIGHT CLOSURE WAS ACHIEVED, WITH NO CSF LEAK FOLLOWING WOUND CLOSURE, NO COMPLICATIONS.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 24746290 ↗
• InjuryJun 17, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A 45-YEAR-OLD FEMALE UNDERWENT CRANIOTOMY FOR A BENIGN TUMOR ON (B)(6) 2025. NO PROCEDURAL COMPLICATIONS OR AES WERE NOTED. AT DISCHARGE ON (B)(6) 2025, THERE WAS NORMAL WOUND HEALING AND NO EVIDENCE OF CSF LEAK. ON (B)(6) 2025 DURING THE 30-DAY FOLLOW-UP, IT WAS NOTED THAT SHE HAS SOME MILD-DRAINAGE AT THE END OF THE INCISION LINE AND WENT ON ANTIBIOTICS. SHE NOTED THAT THERE WASN'T DRAINAGE HOWEVER IN THE WEEK LEADING UP TO THIS. PATIENT WENT TO ER ON (B)(6) 2025 DUE TO PURULENT DRAINAGE AND WAS ADMITTED; PATIENT WAS TAKEN TO OR ON (B)(6) 2025 FOR INCISION AND DRAINAGE. SUBJECT WAS DISCHARGED ON (B)(6) 2025 WITHOUT FURTHER COMPLICATION.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22235758 ↗
• InjuryMay 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WORSENING BACK PAIN AND PARAESTHESIAS IN ALL FOUR EXTREMITIES SEVERAL WEEKS AFTER RECEIVING THE CRANISEAL DURAL SEALANT DEVICE IN A CRANIOTOMY. MRI IMAGING CONFIRMED FLUID COLLECTION POSTERIOR TO THE CRANIECTOMY/LAMINECTOMY SITE.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 22009385 ↗