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).
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.
Cracks or leaks in the stopcocks can cause improper drainage of cerebrospinal fluid, leading to potential complications like infection or inaccurate pressure readings. This is especially concerning for patients who rely on the system to monitor brain health.
Patients using the Exacta External Drainage and Monitoring System for cerebrospinal fluid drainage or intracranial pressure monitoring are most at risk. The recall affects specific model numbers and lot numbers listed in the notice.
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.
Look for model numbers and lot numbers listed in the recall notice to determine if your Exacta External Drainage and Monitoring System is affected.
Medtronic is recalling these systems due to complaints reporting cracks or leaks in the stopcocks, which could lead to improper drainage of cerebrospinal fluid and inaccurate intracranial pressure monitoring.
Check the product label for model numbers and lot numbers to see if it's affected. The recall notice lists specific model numbers and lot numbers that are affected.
The recall notice does not specify a remedy, so affected units should be checked for cracks or leaks and replaced if necessary.
We’ve drafted a message you can send Medtronic Neurosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0662-2025 — Medtronic Neurosurgery Medtronic Neurosurgery Hello, I own a Medtronic Neurosurgery that is covered by recall Z-0662-2025 from Medtronic Neurosurgery. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
