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.
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, 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…
- 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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