Recall Z-1923-2014— Medtronic Neurosurgery
Class I · Terminated
Class I FDA medical device recall by Medtronic Neurosurgery, initiated 2014-06-09, terminated 2015-01-14. It names one FDA 510(k) clearance: K984053. Product: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. 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.. Reason: 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..
- Recalling firm
- Medtronic Neurosurgery
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-06-09
- Terminated
- 2015-01-14
- Firm location
- Goleta, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.