Recall Z-1166-2024— Medtronic Neurosurgery
Class I · Ongoing
Class I FDA medical device recall by Medtronic Neurosurgery, initiated 2024-01-22. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Potential for catheter disconnection from the patient line stopcock connectors..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-01-22
- Firm location
- Irvine, CA, United States
Product description
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.
Reason for recall
Potential for catheter disconnection from the patient line stopcock connectors.
Data sourced from openFDA. This site is unofficial and independent of the FDA.