FDA Recall Database: Class I Recall: Exacta External Drainage and Monitoring System: 27581 KIT… by Medtronic Neurosurgery

Key facts

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of 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). should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Medtronic Neurosurgery. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Medtronic Neurosurgery should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Medtronic Neurosurgery directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

Medtronic Neurosurgery’s FDA history

Argus HQ has recorded 9 total FDA actions tied to Medtronic Neurosurgery: 0 warning letters, 9 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Why was Exacta External Drainage and Monitoring System: 27581 KIT 2 recalled?

FDA's recall record states the reason as: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Who should I contact about this recall?

Contact Medtronic Neurosurgery directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Medtronic Neurosurgery had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 9 total FDA actions tied to Medtronic Neurosurgery, including 9 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-0662-2025.

Related enforcement actions

• Recall: Medtronic Neurosurgery — Class I recall: Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SI… →
• Recall: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site… →
• Recall: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sit… →
• Recall: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Site… →
• Recall: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site… →
• Recall: Medtronic Neurosurgery — Class I recall: Medtronic Duet External Drainage and Monitoring System, Interlink Injection Site… →
• Recall: Medtronic Neurosurgery — Class II recall: Medtronic REF 46915 Duet External Drainage and Monitoring system, Interlink Inje… →
• Recall: Medtronic Neurosurgery — Class II recall: Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUR… →