Medtronic Neurosurgery Recalls
7 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (7)
- Class I
November 1, 2024
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN 27732 EDM 27732 EXACT
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
- Class I
November 1, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
- Class I
January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce in
Potential for catheter disconnection from the patient line stopcock connectors.
- Class I
January 22, 2024
Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure
Potential for catheter disconnection from the patient line stopcock connectors.
- Class I
January 22, 2024
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 in
Potential for catheter disconnection from the patient line stopcock connectors.
- Class I
January 22, 2024
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 intracr
Potential for catheter disconnection from the patient line stopcock connectors.
- Class I
January 22, 2024
Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure a
Potential for catheter disconnection from the patient line stopcock connectors.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.