Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VAL

FDA device recall Z-0661-2025 · posted 2024-12-19 · Open, Classified

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).

Action taken

On 11/01/2024, the firm sent an URGENT: MEDICAL DEVICE CORRECTION Letter via US mail to customers informing them that through customer complaints, the firm is aware of potential cracking and leaking in the "stopcock" components on the Becker and Exacta External Drainage and Monitoring Systems. Customer are instructed to: Recommended Mitigations: -Prior to use, inspect all stopcocks and connections to ensure that connections are secure and there are no visible cracks in the stopcocks. If cracks or leaks are identified, do not use return the device to Medtronic. -The system must be pre-filled with sterile isotonic saline solution prior to connecting to the patient and all connections checked to ensure that fittings (connections) are tight and leak-free. -All connections should be finger tightened. Over tightening can cause cracks and leaks to occur. -After cleaning with alcohol, or a disinfectant containing alcohol, allow to air dry completely prior to connecting the system. Patient Management Recommendations: -If system develops cracks/leaks during use, replace using sterile technique and return the damaged system to Medtronic. If leaks occur with the Patient Line Stopcock, consider application of a hemostat or other clamp to the proximal patient line while coordinating a replacement if occlusion of the patient line does not create a risk to the patient. -In the product labeling, all patients with EDMS should be monitored for evidence of infection. If cracks or leaks, the system should be replaced, and the patient should continue to be monitored for evidence of infection. If customer chooses to return unused product contact Medtronic Customer Service via email: rs.jaxcustomerservice@medtronic.com, or Phone: 1-800-874-5797 Option 1, and mention FA1452, to initiate return process. For questions-contact Medtronic Rep/Medtronic Technical Support (US) at 1-888-826-5603and reference FA1452.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GWM

Quantity affected

65,810 units

Distribution

Worldwide distribution. US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colom

Date initiated

2024-11-01

Date posted

2024-12-19

Location

Fort Worth, TX

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