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CODMAN BACTISEAL NS0338Recalls & reported problems

Cerenovus, Inc. · CODMAN BACTISEAL Clear with Barium Stripe Ventricular Catheter, 15cm Includes: Stylet, Right Angle Adapter and Information Manual · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886704045151), received between Oct 24, 2021 and Oct 24, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

1 other recall cover devices cleared under the same FDA submission (K031123); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Obstruction of Flow1

Patient problems

  • Cerebral Edema1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryOct 24, 2021Obstruction of Flow; Obstruction of Flow

    1 OF 2 REPORTS. OTHER MFG REPORT NUMBER: 3013886523-2021-00447. A PHYSICIAN REPORTED A PATIENT HAD A BLOCKAGE REQUIRING REVISION SURGERY. THE BACTISEAL VENTRICULAR CATHETER AND THE CODMAN PRECISION VALVE WITH SIPHONGUARD HAVE BEEN IMPLANTED VIA VP SHUNT FOR 7 WEEKS IN A PATIENT WHO¿S BEEN TREATED FOR A TUMOR. THE PATIENT HAS NOT BEEN ACTIVE AND HE PRESENTED WITH A FLUID COLLECTION AND SYMPTOMS OF HIGH INTRACRANIAL PRESSURE. A REVISION SURGERY WAS PERFORMED AND IT WAS FOUND THAT THE VALVE IS ALMOST COMPLETELY SHEARED IN HALF. IT WAS SITTING ON THE TOP OF HIS HEAD, NOT IN A MOBILE AREA.

    Patient problems: Cerebral Edema

    MAUDE report 12686923 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031123. One submission often covers many models, so check the product and lot details in each record.

  • Z-1354-2021 · Mar 17, 2021 · Terminated
    CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Numb

Other Shunt, central nervous system and components devices

All Shunt, central nervous system and components devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.