Agency classClass IOur severity:Severe FDA (Devices)·Z-1923-2014·Announced 2014-07-09

Medtronic Duet External Drainage System Tubing Disconnection Recall

Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may become disconnected from the stopcock.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock."

Plain-English summary

Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems, including SmartSite Injection Sites and Ventricular Catheters (Catalog No. 46916). The recall involves 1,187 units distributed worldwide to the United States, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and the United Kingdom.

The recall is being conducted because the patient line tubing in these systems may become disconnected from the patient line stopcock. The device is intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid region.

Healthcare providers and patients should contact Medtronic Neurosurgery for instructions on how to proceed with the recall and replacement of the affected devices.

The recalled product

Product: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar…
Manufacturer: Medtronic Neurosurgery
Category: Medical Device — Neurosurgery
Hazard: tubing-disconnection
Affected units: 1,187

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 5 recalled by Medtronic Neurosurgery under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Medtronic Neurosurgery

See all →

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FDA (Devices) · 2024-03-06
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Medtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06

Same hazard · tubing disconnection