Recall Z-0662-2025 ยท GWM Device, Monitoring, Intracranial Pressure
Medtronic Neurosurgery
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 46
| Date | Dec 19, 2024 (initiated Nov 1, 2024) |
| Status | Open, Classified |
| Reason | Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS). |
| Root cause | Under Investigation by firm |
| Action | 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 w |
| Quantity | 258,367 units |
| Distribution | 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, Fren |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200456 | Becker External Drainage and Monitoring System Medtronic, Inc., Mar 26, 2020 |