Medtronic Duet Catheter System Recalled for Potential Disconnection Risk
Medtronic Duet External Drainage System catheters may disconnect from stopcocks, potentially compromising cerebrospinal fluid management. The FDA Class I recall affects 3,889 units distributed worldwide.
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: The FDA's own Class I classification establishes a minimum severity of Severe. This rating is further supported by the critical nature of the device—used to manage intracranial pressure in neurosurgical patients—where catheter disconnection could compromise essential medical function.
Plain-English summary
Medtronic Neurosurgery is recalling the Duet External Drainage and Monitoring System with Interlink Injection Sites and Lumbar Catheter (REF 46917) due to the potential for catheter disconnection from the patient line stopcock connectors. Approximately 3,889 units have been distributed worldwide.
The device is used in neurosurgical and neurocritical care settings to drain cerebrospinal fluid (CSF) and reduce intracranial pressure. Disconnection of the catheter from the stopcock connector could interrupt or compromise CSF drainage.
The recalled devices were distributed nationally across all U.S. states and the District of Columbia, as well as internationally to multiple countries including Canada, United Kingdom, Germany, Australia, and others. Affected lot numbers have been identified by the manufacturer.
The recalled product
- Product
- Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, 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-failure
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: 222277587 00613994445407
- 223565027 00763000624804
- 223580362 00763000624804
- 223698572 00763000624804
- 223734523 00763000624804
- 223999040 00763000406028
- 224301720 00763000406028
- 224302820 00613994445407
- 224973997 00613994445407
- 224990852 00613994445407
- 224990870 00613994445407
- 224990871 00613994445407
- 225198822 00613994445407
- 226490967 00763000624804
- 226517899 00763000624804
- 226546799 00613994445407
- 226571115 00613994445407
- 226665388 00763000624804
- 226665395 00613994445407
- 226734688 00763000624804
Distribution
Distributed nationwide across the United States.
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