FDA Device recall Z-0662-2025
Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED…
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of Exacta External Drainage and Monitoring System: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK 27666 ED… by Medtronic Neurosurgery, citing due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0662-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-11-01 |
| Published | 2024-12-25 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Neurosurgery |
| Distribution | US |
Product
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 EXACTA W/NDL-LS INJ. ST W/CAP 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ 27795 EDMS 27795 EXACTA 100ML CATH 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML The Exacta external drainage and monitoring system (EDMS) is a system for externally draining and monitoring cerebrospinal fluid (CSF) and monitoring intracranial pressure (ICP).
Reason
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Identifiers
| code_info | Product Number and Description: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM UDI-DI/GTIN code: 00763000333478 Lot Numbers: 2…Product Number and Description: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM UDI-DI/GTIN code: 00763000333478 Lot Numbers: 219434737 219792667 220703679 221213992 221262137 221368619 221482482 221744146 222163800 224643556 225336427 225727016 226111266 226490968 227188117 227332070 227669616 227762294 228914035 228957823 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK UDI-DI/GTIN code: 00763000333492 Lot Numbers: 219390373 219631712 219792681 219888963 220475062 220522923 221159131 221262142 221525913 221744147 222083286 222277590 222658559 223027467 223165952 223300957 224083868 224289845 224438296 225279638 225336428 226111267 226366019 226490969 227188114 227332071 227951891 228081263 228579143 228783458 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN UDI-DI/GTIN code: 00763000333515 Lot Numbers: 219390375 219603331 219792673 220100028 220236200 220236201 220286893 220288205 220293731 220295164 220295420 220295421 220315153 220315154 221133364 221303416 221687758 221860411 222083287 222163798 2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2025%22
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