Use cautionMedical device recall · FDA · Published November 1, 2024
Medtronic Exacta External Drainage System: Cracks or Leaks in Stopcocks
Medtronic recalls Exacta External Drainage and Monitoring Systems with cracks or leaks in stopcocks due to complaints. Affected units include specific model numbers and lot numbers listed in the recall notice.
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
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📍Recalling firmMedtronic Neurosurgery4620 North Beach Street · Fort Worth, TX 76137
✎ GovInfoNow plain-language explainer
Medtronic is recalling Exacta External Drainage and Monitoring Systems that have reported cracks or leaks in stopcocks. This could lead to improper drainage of cerebrospinal fluid and intracranial pressure monitoring, which is critical for patients with brain injuries or spinal conditions. Read more at govinfonow.com/recall/53593-medtronic-exacta-external-drainage-system-cracks-or-leaks-in-stopcocks.
“Medtronic Exacta External Drainage System: Cracks or Leaks in Stopcocks.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53593-medtronic-exacta-external-drainage-system-cracks-or-leaks-in-stopcocks. Based on FDA recall #Z-0662-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0662-2025%22&limit=1).
The FDA announced on Nov. 1, 2024, that Medtronic Neurosurgery is recalling its Exacta External Drainage and Monitoring System due to stopcock cracks and leaks. The agency classified the recall as Class I.
How to tell if you have it
Brand: Medtronic Neurosurgery
Product: Exacta External Drainage and Monitoring System
Model Numbers: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM, 27636 EDM 27636 EXACTA, 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 recall addresses complaints of cracks and leaks in the stopcocks associated with the system. The Exacta external drainage and monitoring system is used for externally draining and monitoring cerebrospinal fluid and monitoring intracranial pressure.
Context
GovInfoNow's records show Medtronic Neurosurgery has 9 other recalls on record since Dec. 20, 2017. Other recent recalls of similar products include the Medtronic Duet Drainage System recall for catheter disconnection risk (Jan. 22, 2024) and the Medtronic Ventriculostomy Kit recall for endotoxin risk (June 17, 2026). Other recent recalls of similar products include the ICU Medical CADD Yellow Medication Cassette Reservoir recall for leakage risk (Aug. 20, 2026) and the B. Braun Medical NES1725KFXL Spinal Epidural Catheter recall for potential tubing cracks (Jan. 29, 2026).
How to tell if you have this one
Check the product label for model numbers like 27581, 27636, 27666, 27732, 27785, 27795, 27861, 46700, or 46705. The recall includes specific lot numbers listed in the notice.
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Ongoing
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.
Look for model numbers and lot numbers listed in the recall notice to determine if your Exacta External Drainage and Monitoring System is affected.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 54 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0662-2025 (November 1, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0662-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.