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 for harm (tubing disconnection) where no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems. The recall involves 760 units of the Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915.
The recall was initiated because the patient line tubing in these systems may become disconnected from the patient line stopcock. The product 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 (intrathecal) region.
The affected units were distributed worldwide, including in the USA, Australia, Belgium, Canada, and other listed countries. Specific lot numbers are provided in the official recall documentation. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the recall.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, Catalog No. 46915. 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
- 760
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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