Becker 27702Recalls & reported problems

Medtronic Ps Medical, Inc. · EDMS 27702 EURO BECKER II GR PT LN · Class 2

Data updated Oct 13, 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.

6 other recalls cover devices cleared under the same FDA submission (K984053); 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.

Recalls naming this device

Nov 1, 2024Open, Classified
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Z-0661-2025 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K984053. One submission often covers many models, so check the product and lot details in each record.

Z-2412-2023 · Jun 28, 2023 · Open, Classified
Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERILE EO, Rx Only
Z-1921-2014 · Jun 9, 2014 · Terminated
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
Z-1923-2014 · Jun 9, 2014 · Terminated
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrosp
Z-1922-2014 · Jun 9, 2014 · Terminated
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. Intended to allow drainage and measurement of cerebrosp
Z-1920-2014 · Jun 9, 2014 · Terminated
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and o
Z-1924-2014 · Jun 9, 2014 · Terminated
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, Catalog No. 46917. Intended to allow drainage and measurement of cerebrospinal

Device details

UDI-DI	`00763000467326`
Brand	Becker
Model	27702
Company	Medtronic Ps Medical, Inc.
Product code	GWM · Device, monitoring, intracranial pressure
Class	Class 2
FDA submission	K984053
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 23, 2024

Device type (GMDN): Cerebrospinal fluid external drainage kit

A collection of sterile devices intended to be used with an intracerebral or spinal infusion/drainage catheter (not included) to collect drained cerebrospinal fluid (CSF) from the brain ventricles or from the lumbar subarachnoid (intrathecal) region as a means of reducing CSF volume and intracranial pressure (ICP). It typically includes devices such as a drip chamber, drainage bag, tubing set, catheter connector, stopcock, and filter. This is a single-use device.

Other Device, monitoring, intracranial pressure devices

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Duet® 46913
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Becker® 46129
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Codman Microsensor® 826631
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All Device, monitoring, intracranial pressure 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 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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