Class 1 Device Recall Becker External Drainage and Monitoring System

• Date Initiated by Firm: November 01, 2024
• Date Posted: December 19, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0661-2025
• Recall Event ID: 95725
• 510(K)Number: K200456
• Product Classification: Device, monitoring, intracranial pressure - Product Code GWM
• Product: Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY VALVE 26040 KIT 26040 BECKER EDMS II 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE 27670 BECKER 27670 STOP BELOW DC NDL-LS IN 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN 27702 EDMS 27702 EURO BECKER II GR PT LN 27761 BECKER 27761 STOP BCNDLESS PATLN 24 27767 BECKER 27767 NO STPCOCK ON PTLN 63 27779 EDMS 27779 BECKER BC NDLESS BOND CONN 27811 EDMS 27811 BECKER GRN PL VCATH 27931 EDMS 27931 BECKER GS TUBING SMARTSITES 46128 EDMS 46128 BECKER II BLUE PT LN 46129 EDMS 46129 EURO BECKER II BLUE PT LN The Becker External Drainage and Monitoring System (Becker EDMS) is a closed system for: 1. Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space. 2. Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
• Code Information: Product Number and Description: 24146 EDMS 24146 BECKER NO Y-SITE UDI-DI/GTIN code: 00763000333423 Lot Numbers: 219712762 220791262 220836565 222082056 226933414 227950454 25120 EDMS II 25120 BECKER W/1-WAY VALVE UDI-DI/GTIN code: 00763000333430 Lot Numbers: 219712914 219890583 219912494 220051377 220490117 221213296 221343122 221482483 222322808 222559082 222810773 223580281 223580282 223580283 225234349 226072076 226810273 227906031 228957822 229230810 UDI-DI/GTIN code: 00763000431297 Lot Number: 228080125 26040 KIT 26040 BECKER EDMS II UDI-DI/GTIN code: 00763000333447 Lot Numbers: 219694908 219728986 219744900 219798954 220018272 220051379 220158549 220158894 220171612 220198300 220458253 220490118 220522916 220564314 220564315 220564316 220651436 220791263 220836806 220883511 220968714 221131925 221158918 221189857 221213294 221303411 221528223 221687661 221743772 221795482 221873433 222620587 222620588 222620589 222658552 222695494 222817388 222817390 222887926 222999289 222999291 222999293 223621049 223621051 223659549 223659552 223659555 223697541 223778300 224032598 224173188 224277829 224387150 224387152 224387154 224437365 224438287 224471872 224471874 224643554 225375789 225727017 226072074 226072077 226090342 226090345 226111240 226111242 226111244 226111268 226150981 226151064 226241860 226288867 226335055 226951038 227188110 227446479 227446507 227490159 227538045 227539127 227585327 227634613 227634615 227666438 227668740 227668742 227735796 227735798 227779089 227862470 227906042 227951886 228841691 228858954 228858956 228858958 228858960 228913261 228914143 229049637 229049643 229100505 229101087 229101091 229101093 229239419 229391821 229542957 UDI-DI/GTIN code: 00763000406066 Lot Numbers: 228027884 228081252 228123193 228123195 228260082 228260606 228287013 228287015 228312659 228312661 228326183 228357011 228357013 228402670 228450311 228450313 228499617 228499618 228783157 27609 BECKER 27609 W/NEEDLESLESS INJ. SITE UDI-DI/GTIN code: 00763000333485 Lot Numbers: 219712763 220400528 222082057 226998769 227862472 UDI-DI/GTIN code: 00763000529307 Lot Number: 228230540 27670 BECKER 27670 STOP BELOW DC NDL-LS IN UDI-DI/GTIN code: 00763000333522 Lot Numbers: 219712765 219887171 220651439 222049071 224032600 224643848 226182608 226490977 229010912 27672 BECKER 27672 ONEWAY VLV Y-SITE PT LN UDI-DI/GTIN code: 00763000333539 Lot Number: 222258694 27702 EDMS 27702 EURO BECKER II GR PT LN UDI-DI/GTIN code: 00763000333553 Lot Numbers: 219887172 220749000 222049069 223697544 224032601 224438305 225375792 225630424 226288866 227585329 227779107 228081264 228913264 229101096 UDI-DI/GTIN code: 00763000467326 Lot Number: 228260612 27761 BECKER 27761 STOP BCNDLESS PATLN 24 UDI-DI/GTIN code: 00763000333577 Lot Numbers: 219887170 220610533 222049070 225198001 226616230 227762295 229393847 27767 BECKER 27767 NO STPCOCK ON PTLN 63 UDI-DI/GTIN code: 00763000333584 Lot Numbers: 219968507 227539144 27779 EDMS 27779 BECKER BC NDLESS BOND CONN UDI-DI/GTIN code: 00763000333591 Lot Numbers: 219712764 219807627 220400529 220461637 223088136 223255544 225198002 226150985 226366029 227467158 227467159 227585567 228123250 228670577 228670578 228670579 228670580 228734465 228783163 UDI-DI/GTIN code: 00763000529345 Lot Numbers: 228179777 228230535 228230536 228260080 228260081 228287012 228312658 228402669 228535135 27811 EDMS 27811 BECKER GRN PL VCATH UDI-DI/GTIN code: 00763000333638 Lot Number: 221343633 27931 EDMS 27931 BECKER GS TUBING SMARTSITES UDI-DI/GTIN code: 00763000333669 Lot Numbers: 219912495 220462686 220763088 221795484 221853177 223270455 224032607 224438289 225234324 225270200 225422436 226180686 226616219 226951446 227188115 227779111 227906188 227906189 46128 EDMS 46128 BECKER II BLUE PT LN UDI-DI/GTIN code: 00763000333676 Lot Numbers: 219603333 219603334 219603335 219642506 219653249 219653255 219656940 219738928 219744775 219798953 219839808 219926903 219988065 219988526 220018274 220522915 220610535 220610536 220677063 220749002 220752016 220836810 220837993 220883519 220935479 220935480 220935481 220952094 220968715 220968724 221091163 221103633 221131924 221262027 221303407 221343621 221343622 221343623 221419373 221419374 221419375 221482530 221579110 221579111 221613870 221614449 221648849 221687761 221744152 221795485 221828781 221873435 222015659 222015660 222049066 222082055 222121356 222218166 222218167 222240778 222240779 222240780 222322809 222322810 222345100 222345101 222413277 222413278 222481090 222523762 222523763 222523765 222530276 222530277 222530278 222581026 222633228 223088137 223088138 223270456 223270457 224032602 224032603 224032604 224032605 224032606 224083875 224083876 224128117 224128509 224173193 224438304 224471685 224515872 224559928 224593528 224643565 224643846 225198808 225198809 225234352 225234353 225279754 225279755 225336438 225336439 225422437 225630425 225675931 225726235 225726236 225726237 225749476 225749477 225795544 225795545 225804025 225804706 225804707 225805226 226420553 226420554 226616231 226616232 226616233 226896331 226896332 226896335 226933415 226933422 226933423 226951447 227446514 227446518 227490161 227490162 227539129 227585330 227585331 227634660 227634661 227669625 227735837 227779113 227862484 227862485 227862506 227906190 227951892 227951893 228000489 228000490 228000491 228620727 228620728 228783449 228783450 228783452 228841696 228859329 UDI-DI/GTIN code: 00763000406073 Lot Numbers: 227906191 228012564 228012565 228029450 228081277 228123253 228123254 228123255 228230537 228230538 228260610 228312663 228312664 228357016 228388891 228388892 228388893 228422468 228422469 228422470 228422472 228422473 228499619 228499620 228512025 228514226 228536235 228579130 228693165 228693406 228693407 228693409 228714965 46129 EDMS 46129 EURO BECKER II BLUE PT LN UDI-DI/GTIN code: 00763000333683 Lot Numbers: 219656939 219744779 219807231 219839809 220018276 220118014 220120890 220120892 220651438 220791265 220791528 220836811 221262143 221262144 221419372 221648850 221796467 222015662 224515873 224643847 225279756 225375791 226072079 226616234 226951448 227446522 227490164 227539130 227585332 227634662 227669626 227735838 227779114 228629471 228914030 228914031 229142581 UDI_DI/GTIN code: 00763000431259 Lot Numbers: 228012786 228029451 228029452 228123256 228260611 228287017 228287018 228311925 228312665
• Recalling Firm/ Manufacturer: Medtronic Neurosurgery; 4620 North Beach Street; Fort Worth TX 76137
• For Additional Information Contact: Rita Greenberg; 612-385-3537
• Manufacturer Reason for Recall: Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
• FDA Determined 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 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.
• Quantity in Commerce: 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GWM