Exacta External Drainage and Monitoring System: 27581 KIT 27581… — Class I medical device recall Z-0662-2025
Ongoing recall by Medtronic Neurosurgery, reported 2024-12-25, distributed nationwide. Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainag
| Recall number | Z-0662-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neurosurgery, Fort Worth, TX, United States |
| Recall initiated | 2024-11-01 |
| Classified | 2024-12-19 |
| Reported by FDA | 2024-12-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BH, CA, CH, CL, CN, CO, CR, CW, CY, CZ, DE, DK, DO, DZ, EG, ES, FI, GB, GH, GR, HK, HN, ID, IL, IS, IT, JM, JO, KE, KW, LB, LV, MA, MT, MY, NI, NL, NO, NZ, OM, PA, PE, PL, PT, QA, RO, SA, SE, SG, SK, TH, TN, TT, TW, UY, VN, ZA |
| Quantity | 258,367 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00763000333478, 00763000333492, 00763000333515, 00763000333560, 00763000333607, 00763000333614, 00763000333645, 00763000333690, 00763000333706 |
| Lot numbers | 219317961, 219317962, 219317963, 219317964, 219317965, 219318226, 219318227, 219318228, 219318229, 219351420, 219351421, 219351422, 219351423, 219351424, 219351425, 219352386, 219390368, 219390369, 219390370, 219390371, 219390372, 219390373, 219390374, 219390375, 219395752, 219434735, 219434736, 219434737, 219434738, 219434739, 219434740, 219434741, 219434742, 219434743, 219434744, 219434745, 219435376, 219481332, 219481359, 219481379 and 460 more |
| Model numbers | 27861 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0662-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.