Medtronic Neurosurgery External Drainage and Monitoring Systems Recall Issued After Injury Reports

Medtronic is warning that certain neurosurgery devices used to drain and monitor cerebrospinal fluid from the brain may be at an increased risk of developing cracks or leaks.

The U.S. Food and Drug Administration (FDA) announced the Medtronic Neurosurgery Draining and Monitoring Systems recall on February 3, warning healthcare providers and customers to inspect all Becker and Exacta External Drainage and Monitoring Systems (EDMS) for cracks or leaks, as these defects could cause serious health risks, including cerebrospinal fluid leaks, infections and even death.

External Drainage and Monitoring Systems are crucial medical devices typically used in a hospital or clinical setting, particularly in neurosurgical and intensive care units. These systems are designed for patients who require precise management of cerebrospinal fluid (CSF) due to conditions like traumatic brain injury, hydrocephalus or brain surgeries that may cause swelling and increased intracranial pressure.

The EDMS uses a complete closed system to safely drain excess CSF from specific areas of the brain while continuously monitoring the fluid’s pressure and flow rate.

Medtronic Neurosurgery first issued an Urgent Medical Device Correction letter for the affected EDMS devices in November 2024, due to the potential risk of the stopcock cracking or leaking.

The manufacturer has become aware of at least 15 injuries related to the issue.

As a result, the FDA has classified this action as a Class I recall, the most serious type, indicating that continued use of the product could result in serious injury or death.

The recall involves both Becker and Exacta EDMS devices from Medtronic Neurosurgery. A full list of the affected products’ Unique Device Identifiers and model numbers can be found in the FDA recall notice.

The correction letter asks providers to inspect all devices for cracks or leaks, discontinue use if defects are found, and monitor all patients using Becker and Exacta EDMS devices for signs of infection. Devices with cracks or leaks should be returned to Medtronic.

The letter also suggests that users employ sterile techniques to pre-fill the system with isotonic saline solution before connecting it to the patient, finger-tighten all connections, allow the device to air-dry completely after cleaning with alcohol, and replace any system that develops cracks or leaks during use.

The manufacturer requests that customers complete and return the customer confirmation form and keep a copy of the notification posted near any affected products to remind users of the issue.

For more information, customers can contact Medtronic Customer Service at rs.jaxcustomerservice@medtronic.com or by phone at 1-800-874-5797, option 1. To start the return process, customers should state the recall code FA1452, along with lot and product numbers when calling.

Customers may also contact their Medtronic representative or technical support at 1-888-826-5603, with reference code FA1452.