Medtronic Duet External Drainage System Tubing Disconnection Recall
Medtronic 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. 46914. These devices are intended to allow the 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 issued because the patient line tubing in these systems may become disconnected from the patient line stopcock. This potential disconnection could compromise the integrity of the drainage and monitoring process.
The affected units 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. A total of 5,744 units are involved in this recall. Healthcare providers and patients should contact Medtronic Neurosurgery for further instructions regarding the replacement or repair of these devices.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. 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
- Hazard
- Affected units
- 5,744
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
Same manufacturer · Medtronic Neurosurgery
See all →- HighMedtronic Neurosurgery Recalls Ventriculostomy Kit Due to High Endotoxin Levels
FDA (Devices) · 2026-07-29
- SevereExacta External Drainage System Stopcocks May Leak or Crack
FDA (Devices) · 2024-12-25
- SevereMedtronic Becker Neurosurgical Drainage Systems Recalled for Cracked and Leaking Stopcocks
FDA (Devices) · 2024-12-25
- SevereMedtronic Duet Catheter System Recalled for Potential Disconnection Risk
FDA (Devices) · 2024-03-06
- SevereMedtronic Duet Ventricular Catheter Recalled for Disconnection Risk
FDA (Devices) · 2024-03-06
Same hazard · tubing disconnection
See all →- HighOxygen masks recalled after complaints of tubing disconnecting during use
FDA (Devices) · 2026-01-14
- HighBaxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk
FDA (Devices) · 2020-06-10
- HighBaxter Gambro Hemodialysis Blood Set Recalled for Tubing Disconnection Risk
FDA (Devices) · 2020-06-10
- HighBaxter Gambro Cartridge Blood Set Recalled for Tubing Disconnection Risk
FDA (Devices) · 2020-06-10
- HighBaxter Gambro Cartridge Blood Transport System Recalled for Tubing Disconnection Risk
FDA (Devices) · 2020-06-10