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Medtronic Neurosurgery FDA Recalls
13 recalls on file across devices, 7 of them Class I and 13 still open. Matched by name to MDT.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Ventriculostomy Kit, REF: 46154Class IIJun 17, 2026Ventriculostomy devices, used during ventriculostomy procedu |
| Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VClass INov 1, 2024Due to complaints received reporting cracks and/or leaks of |
| Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDClass INov 1, 2024Due to complaints received reporting cracks and/or leaks of |
| Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Ventricular Catheter, REF 46915, SterClass IJan 22, 2024Potential for catheter disconnection from the patient line |
| Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, REF 46913, Sterile EO, Rx Only. Used Class IJan 22, 2024Potential for catheter disconnection from the patient line |
| Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. UsedClass IJan 22, 2024Potential for catheter disconnection from the patient line |
| Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EClass IJan 22, 2024Potential for catheter disconnection from the patient line |
| Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, REF 46916, SterClass IJan 22, 2024Potential for catheter disconnection from the patient line |
| Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Injection sites, Ventricular Catheter, STERIClass IIJun 28, 2023Product labeling contains incorrect expiration date |
| Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DURClass IIJun 13, 2023Dura regeneration matrix may have out-of-specification endot |
| Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: Class IIJan 11, 2021Potential for variation in radiopaque marking visibility und |
| Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs: 22011 L- SHUNT 22011 L Class IIJan 11, 2021Potential for variation in radiopaque marking visibility und |
| Medtronic Delta CSF (Cerebro Spinal Fluid) -Flow Control Valves for the following CFNs/REF numbers: 24048 - VALVE 24Class IIJan 11, 2021Potential for variation in radiopaque marking visibility und |