CODMAN® BACTISEAL® NS0340Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10381780524076), received between Mar 24, 2024 and Feb 20, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 20, 2026Obstruction of Flow

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814) AND BACTISEAL CATHETER (ID NS0340) WERE IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (V-P) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. CEREBROSPINAL FLUID IS NOT FLOWING WELL THEREFORE THE DEVICE WAS EXPLANTED. THE PATIENT DIDNT EXPERIENCED ANY SIGNS AND SYMPTOMS OF OBSTRUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400454 ↗
• MalfunctionJan 30, 2025Shielding Failure; Shielding Failure

  3 OF 3 REPORTS (SAME FAILURE, SAME CATALOG ID NUMBER, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBERS: 3013886523-2025-00024, 3013886523-2025-00025. A FACILITY REPORTED A BACTISEAL CATHETER KIT (ID NS0340) WAS IMPLANTED ON (B)(6) 2024AND IT COULD NOT BE OBSERVED ON X-RAY AFTER IMPLANTATION. NO PATIENT INJURY/CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274945 ↗
• MalfunctionJan 30, 2025Shielding Failure; Shielding Failure

  2 OF 3 REPORTS (SAME FAILURE, SAME CATALOG ID NUMBER, DIFFERENT PATIENTS). OTHER MFG REPORT NUMBERS: 3013886523-2025-00024, 3013886523-2025-00026. A FACILITY REPORTED A BACTISEAL CATHETER KIT (ID: NS0340) WAS IMPLANTED ON (B)(6) 2024 AND IT COULD NOT BE OBSERVED ON X-RAY AFTER IMPLANTATION. NO PATIENT INJURY/CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21274943 ↗
• InjuryMay 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED A CERTAS VALVE (ID 828814) AND BACTISEAL CATHETER (ID NS0340) WERE IMPLANTED DUE TO UNKNOWN REASON VIA VENTRICULOPERITONEAL (V-P) SHUNT ON UNKNOWN DATE WITH UNKNOWN SETTING. THERE WAS A LEAKAGE OF CEREBROSPINAL FLUID (CSF) IN THE CHAMBER. A DEBRIS WAS SEEN IN THE VALVE, HOWEVER NO DAMAGE WAS FOUND IN THE VALVE. THEREFORE, BOTH THE VALVE AND CATHETER WERE REMOVED. ACCORDING TO THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE CATHETER WAS REPLACED. THE ESTIMATE AMOUNT FOR CSF LEAKAGE IS NOT KNOWN. IT IS ALSO UNKNOWN IF THE PATIENT HAS ANY SIGNS OR SYMPTOMS RELATED TO THE CSF LEAK. THE PATIENT'S CURRENT STATUS IS UNKNOWN.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 19346834 ↗
• InjuryMar 24, 2024Obstruction of Flow; Obstruction of Flow

  N/A.

  Patient problems: Insufficient Information

  MAUDE report 18966531 ↗