FDA Device recall Z-0661-2025
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…
- FDA Device
- Class I
- ongoing
- Published 2024-12-25
On 2024-12-25 the FDA classified a Class I recall of 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… 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-0661-2025 |
| 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
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 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
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: 24146 EDMS 24146 BECKER NO Y-SITE UDI-DI/GTIN code: 00763000333423 Lot Numbers: 2197127…Product Number and Description: 24146 EDMS 24146 BECKER NO Y-SITE UDI-DI/GTIN code: 00763000333423 Lot Numbers: 219712762 220791262 220836565 222082056 226933414 227950454 25120 EDMS II 25120 BECKER W/1-WAY VALVE UDI-DI/GTIN code: 00763000333430 Lot Numbers: 219712914 219890583 219912494 220051377 220490117 221213296 221343122 221482483 222322808 222559082 222810773 223580281 223580282 223580283 225234349 226072076 226810273 227906031 228957822 229230810 UDI-DI/GTIN code: 00763000431297 Lot Number: 228080125 26040 KIT 26040 BECKER EDMS II UDI-DI/GTIN code: 00763000333447 Lot Numbers: 219694908 219728986 219744900 219798954 220018272 220051379 220158549 220158894 220171612 220198300 220458253 220490118 220522916 220564314 220564315 220564316 220651436 220791263 220836806 220883511 220968714 221131925 221158918 221189857 221213294 221303411 221528223 221687661 221743772 221795482 221873433 222620587 222620588 222620589 222658552 222695494 222817388 222817390 222887926 222999289 2229992 |
|---|
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-0661-2025%22
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