CerebroFlo EVD Catheter Set 37.550.501Recalls & reported problems

Arkis Biosciences Inc. · The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10866614000105), received between Mar 17, 2022 and Mar 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 other recall cover devices cleared under the same FDA submission (K170599); 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

Device problems

Leak/Splash1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

InjuryMar 17, 2022Leak/Splash; Leak/Splash
CLINICAL STUDY: PATIENT HAD ON (B)(6) 2021 A CEREBROFLO EVD CATHETER PLACED TO TREAT SECONDARY INTRAVENTRICULAR HEMORRHAGE (IVH) DUE TO RUPTURED ANEURYSM. ON (B)(6) 2021 IT WAS REPORTED THE CEREBROFLO EVD CATHETER WAS LEAKING AT EXIST SITE. A CT SCAN ON (B)(6) REVEALS SOME AIR IN THE VENTRICLES AND IT WAS CONSIDERED REPLACING HER EVD, BUT WAS DEFERRED AS IT WAS FELT THE AIR WAS ENTRAINED FROM AROUND THE EVD RATHER THAN DUE TO MALFUNCTION OF EVD. AN ADDITIONAL SUTURE WAS PLACED AT THE EXIT SITE AND THE OUTCOME WAS RECOVERED/RESOLVED AND THE CATHETER WAS REMOVED ON (B)(6) 2022.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13790695 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170599. One submission often covers many models, so check the product and lot details in each record.

Z-2173-2026 · Apr 10, 2026 · Open, Classified
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane

Device details

UDI-DI	`10866614000105`
Brand	CerebroFlo EVD Catheter Set
Model	37.550.501
Company	Arkis Biosciences Inc.
Product code	JXG · Shunt, Central Nervous System And Components
Class	Class 2
FDA submission	K170599
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 26, 2024

Device type (GMDN): Intracerebral infusion/drainage catheter, short-term

A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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