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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential mechanical failure (tubing disconnection) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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
- 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 →Related recalls
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