Duet® 46916 (UDI 00763000624798)Recalls & reported problems

Medtronic Ps Medical, Inc. · EDMS 46916 DUET BLUECORE WITH VCATH · Class 2

All models of Duet (16)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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 16, 2026.

Recalls naming this device

Jan 22, 2024Open, Classified
Potential for catheter disconnection from the patient line stopcock connectors.
Z-1165-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`00763000624798`
Brand	Duet®
Model	46916
Company	Medtronic Ps Medical, Inc.
Product code	PCB · External cerebrospinal fluid (CSF) diversion
Class	Class 2
FDA submission	DEN120017
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Dec 23, 2024

Device type (GMDN): Ventricular cerebrospinal fluid drainage catheterization kit

A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF) as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device.

Other External cerebrospinal fluid (CSF) diversion devices

Duet® 46915
Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion
2 recalls1 report
Duet® 46914
Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion
1 recall15 reports
Duet® 46914
Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion
1 recall7 reports
Duet® 46916
Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion
1 recall4 reports
Duet® 46917
Medtronic Ps Medical, Inc. · External cerebrospinal fluid (CSF) diversion
1 recall0 reports

All External cerebrospinal fluid (CSF) diversion devices →

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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