Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 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

U.S. FDA — Device Enforcement · United States · 2024-11-01 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0662-2025
Date of alert
2024-11-01
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Medtronic Neurosurgery
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000333478
Reported risk: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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