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).
Recall
- Recall Number
- Z-0662-2025
- Event Number
- 95725
- Firm
- Medtronic Neurosurgery
- FEI Number
- 3015531529
- Product Code
- GWM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- November 1, 2024
- Posted
- December 19, 2024
- Address
- 4620 North Beach Street, Fort Worth, TX, 76137
Description
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).
Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
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: [email protected], 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.
Worldwide distribution. US nationwide including Puerto Rico; Algeria, Argentina, Australia, Austria, Bahrain, Barbados, Bosnia And Herzegovina, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, French Guiana, French Polynesia, Germany, Ghana, Greece, Guadeloupe, Honduras, Hong Kong, Iceland, Indonesia, Israel, Italy, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Lao People s Democratic Republic, Latvia, Lebanon, Libya, Malaysia, Malta, Mauritania, Morocco, Myanmar, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Republic of Tanzania, Thailand, Trinidad And Tobago, Tunisia, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay, Vietnam, and Yemen.
258,367 units