Medtronic Duet External Drainage System catheter disconnection risk recalled
Medtronic recalls Duet External Drainage and Monitoring System catheter units (REF 46915) due to potential disconnection from stopcock connectors. Worldwide distribution includes 14,139 units.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification indicates serious risk of harm. The device is essential for critical neurological care; catheter disconnection could interrupt life-sustaining CSF drainage in patients with elevated intracranial pressure.
Plain-English summary
Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter (REF 46915), a sterile, FDA-regulated medical device used to drain cerebrospinal fluid (CSF) and reduce intracranial pressure. The recall affects 14,139 units distributed worldwide.
The catheter may disconnect from the patient line stopcock connectors. This potential disconnection could interrupt CSF drainage and compromise the critical therapeutic function of the device.
Affected units have been distributed throughout the United States and internationally to approximately 50 countries including Argentina, Australia, Canada, China, Germany, Japan, United Kingdom, and others. Patients and healthcare providers with this device should contact Medtronic Neurosurgery with their device lot numbers to determine if their units are affected and to receive guidance on appropriate management.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.
- Manufacturer
- Medtronic Neurosurgery
- Hazard
- catheter-disconnection
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Number/GTIN: 221604935 00613994445384
- 221827829 00613994445384
- 222121359 00613994445384
- 222125124 00613994445384
- 222163140 00613994445384 222163787 00613994445384
- 222163788 00613994445384
- 222204095 00613994445384
- 222204097 00613994445384
- 222439027 00613994445384
- 222439028 00613994445384
- 222439029 00613994445384 222658560 00613994445384
- 222658561 00613994445384
- 222724791 00613994445384
- 222724792 00613994445384
- 222766469 00613994445384
- 222766470 00613994445384
- 222816525 00613994445384
- 222817386 00613994445384
- 222817387 00613994445384 223818451 00763000624781
- 223818452 00763000624781
Distribution
Distributed nationwide across the United States.
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