# FDA recall Z-0662-2025

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

## 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 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-0662-2025
- **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-0662-2025

## Citation

> AI Analytics. FDA recall Z-0662-2025. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0662-2025. Source: US FDA. Licensed CC0.

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