# FDA recall Z-0661-2025

> **Medtronic Neurosurgery** · Class I · device recall initiated 2024-11-01.

## 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 for recall

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

## Distribution

Worldwide distribution.  US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.

## Key facts

- **Recall number:** Z-0661-2025
- **Recalling firm:** Medtronic Neurosurgery
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-11-01
- **Report date:** 2024-12-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Fort Worth, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2025

## Citation

> AI Analytics. FDA recall Z-0661-2025. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0661-2025. Source: US FDA. Licensed CC0.

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