MIL-OSI USA: Pressure Monitoring Device Recall: Medtronic Neurosurgery Issues Correction for Becker and Exacta External Drainage and Monitoring Systems Due to Cracks And/Or Leaks in Stopcocks

This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.

Affected Product

• Product Names: Becker External Drainage and Monitoring System, Exacta External Drainage and Monitoring System (EDMS)
• Unique Device Identifier (UDI)/Model: See full list of affected products.

What to Do  

• Inspect all Becker and Exacta EDMS devices for cracks or leaks.
• If there are cracks and/or leaks, do not use the these devices. 
• Monitor all patients with EDMS for evidence of infection. 

In November 2024, Medtronic Neurosurgery sent all affected customers an Urgent Medical Device Correction recommending the following actions:

For providers

• Inspect all stopcocks and connections before use to make sure connections are secure and there are no visible cracks.
• Do not use the device if cracks or leaks are identified. Return it to Medtronic.
• Pre-fill the system with sterile isotonic saline solution before connecting to the patient.
• Check all connections to make sure fittings (connections) are finger-tight and leak-free.
• Finger tighten all connections. Over tightening can cause cracks and leaks. 
• Allow device to air dry completely after cleaning with alcohol or a disinfectant containing alcohol. 
• Replace any system that develops cracks or leaks during use using sterile technique. Return the damaged system to Medtronic. 
  • Consider application of hemostat or other clamp to the proximal patient line during replacement if blocking the patient line will not create patient risk. 
• Monitor all patients with EDMS for evidence of infection. 
• Replace any system with cracks or leaks and continue monitoring the patient for evidence of infection.

For customers

• Complete and return the enclosed customer confirmation form to acknowledge the letter. 
• Post a copy of the notification near impacted product as a reminder of the issue and recommended actions. 
• Keep a copy of the letter and completed response form for institutional records.
• Contact Medtronic Customer Service via email: rs.jaxcustomerservice@medtronic.com, or phone: 1-800-874-5797 Option 1, and mention FA1452, to initiate the returns process.

Medtronic will honor return of unused product for a full credit. 

Reason for Recall  

Medtronic Neurosurgery is recalling certain Becker and Exacta EDMS due to a risk for cracks and or leaks in device stopcocks. 

The use of affected product may cause serious adverse health consequences, including leaks of cerebrospinal fluid, infections, and death.  
 
There have been 15 reported injuries. There have been no reports of death.  

Device Use

Becker and Exacta External Drainage and Monitoring Systems (EDMS) provide a complete closed system to drain cerebrospinal fluid (CSF) from specific parts of the brain and to monitor CSF pressure and flow rate from these areas. 

Contact Information  

Customers in the U.S. with questions about this recall should contact their Medtronic representative or Medtronic Technical Support at 1-888-826-5603 (reference FA1452). 

Full List of Affected Devices (if applicable)  

Additional FDA Resources (listed in order of most to least recent):  

• FDA’s Enforcement Report
• Medical Device Recall Database

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.