Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic Neurosurgery is recalling Duet External Drainage and Monitoring Systems because the patient line tubing may disconnect 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 mechanical defect (tubing disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems, Catalog No. 46913. The recall involves 3,026 units of Interlink Injection Sites intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
The recall is being conducted because the patient line tubing in these systems may become disconnected from the patient line stopcock. This defect could potentially compromise the integrity of the drainage and monitoring system.
The affected products were distributed worldwide, including in the USA, 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 specific lot numbers involved are 206923217, 207096627, 207096630, 207187691, 207224897, 207269986, 207466017, 207565424, 207565425, 207659575, 207659576, 207739874, 207875274, 207945037, and 207982847. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions on how to proceed with the recall.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Catalog No. 46913. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathe
- Manufacturer
- Medtronic Neurosurgery
- Category
- Medical Device — Neurosurgery
- Affected units
- 3,026
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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