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U.S. Department of Health and Human Services

Class 1 Device Recall Exacta External Drainage and Monitoring System

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 Class 1 Device Recall Exacta External Drainage and Monitoring Systemsee related information
Date Initiated by FirmNovember 01, 2024
Date PostedDecember 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0662-2025
Recall Event ID 95725
510(K)NumberK200456 
Product Classification Device, monitoring, intracranial pressure - Product Code GWM
ProductExacta 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).
Code Information Product Number and Description: 27581 KIT 27581 EXACTA W/EDM VCATH 35CM UDI-DI/GTIN code: 00763000333478 Lot Numbers: 219434737 219792667 220703679 221213992 221262137 221368619 221482482 221744146 222163800 224643556 225336427 225727016 226111266 226490968 227188117 227332070 227669616 227762294 228914035 228957823 27636 EDM 27636 EXACTA W/BRAIDED CORD LOCK UDI-DI/GTIN code: 00763000333492 Lot Numbers: 219390373 219631712 219792681 219888963 220475062 220522923 221159131 221262142 221525913 221744147 222083286 222277590 222658559 223027467 223165952 223300957 224083868 224289845 224438296 225279638 225336428 226111267 226366019 226490969 227188114 227332071 227951891 228081263 228579143 228783458 27666 EDM 27666 EXCTA W GLUE STPCK GR PT LN UDI-DI/GTIN code: 00763000333515 Lot Numbers: 219390375 219603331 219792673 220100028 220236200 220236201 220286893 220288205 220293731 220295164 220295420 220295421 220315153 220315154 221133364 221303416 221687758 221860411 222083287 222163798 222204316 222658830 222810946 223027466 223052246 223070520 223070521 223165951 223255543 224083873 224083874 224342648 224593537 225234323 225631426 226111270 226111271 226366028 226516611 226516612 226516613 227136783 227381120 227381121 227634653 227669617 227735833 227779106 228230541 228858404 228858405 228957825 229010910 229101095 229189950 27732 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP UDI-DI/GTIN code: 00763000333560 Lot Numbers: 219888964 220197686 220703680 221059818 221068867 221068879 221213993 221744148 228230542 228501266 27785 EDMS 27785 EXACTA 50ML BC NDLESS INJ UDI-DI/GTIN code: 00763000333607 Lot Numbers: 219390374 219603332 219792676 220249832 220258472 220258473 221159127 221303417 221687759 222163799 224515878 224643553 225198003 225675933 225795996 226366027 227136784 227634657 228081271 229010916 27795 EDMS 27795 EXACTA 100ML CATH UDI-DI/GTIN code: 00763000333614 Lot Numbers: 219694828 221482480 221922072 27861 EDMS 27861 EXACTA 50ML ANTIRFLUX GRNPL UDI-DI/GTIN code: 00763000333645 Lot Numbers: 221687760 227188116 227906187 46700 SYSTEM 46700 EXACTA DISP. DRAINAGE UDI-DI/GTIN code: 00763000333690 Lot Numbers: 219317961 219317962 219317963 219317964 219317965 219318226 219318227 219318228 219318229 219351420 219351421 219351422 219351423 219351424 219351425 219352386 219390368 219390369 219390370 219390371 219434735 219434736 219434738 219434739 219434740 219434741 219434742 219434743 219434744 219434745 219435376 219481332 219481359 219481379 219481420 219481443 219481461 219511967 219512845 219513667 219513669 219513670 219528348 219528351 219528353 219543686 219543714 219603043 219603044 219603045 219603327 219603329 219656942 219656943 219656944 219656945 219683574 219683575 219738003 219738930 219742408 219792669 219836483 219837605 219838586 219838587 219838588 219838589 219854730 219854733 219890567 219890568 220105879 220105880 220156494 220156495 220156496 220156497 220171611 220198178 220198179 220279972 220282626 220288204 220295416 220295417 220295418 220313865 220315146 220315147 220315148 220445512 220455469 220522924 220527536 220610537 220610538 220651432 220651433 220703684 220703685 220749667 220749668 220791470 220791471 220836817 220836818 220836928 220883515 220883516 220935797 220935798 220935827 220952095 220964564 220968719 220968720 221034568 221034569 221092006 221099016 221133365 221159141 221213991 221262141 221482531 221526852 221526853 221528497 221569958 221569959 221598133 221598134 221604937 221614446 221614447 221614448 221646710 221648851 221652156 221687227 221687228 221687229 221744155 221777133 221777135 221777136 221796470 221826632 221827836 221873441 221874035 221916510 221916666 221916667 221955180 221955181 221955182 221955183 221955184 221955185 221955226 222083288 222088592 222121365 222125827 222125828 222125829 222141577 222152806 222163790 222163791 222163792 222163793 222163794 222163795 222163796 222163797 222204311 222204312 222204313 222204314 222204315 222240774 222295173 222464026 222584505 222586146 222595117 222595118 222595119 222595343 222595344 222620332 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227862507 227862508 227862509 227906192 227951894 227951895 227951896 227951897 227951898 227951899 227951900 228029455 228029456 228081280 228081281 228081282 228081283 228123257 228123258 228123260 228123261 228180045 228192554 228192555 228230689 228260619 228260620 228287025 228287306 228287307 228314366 228314367 228314368 228314369 228314370 228357021 228357022 228357023 228358146 228402746 228402747 228450321 228450322 228450323 228450324 228501267 228579145 228579226 228579227 228611718 228611719 228611720 228643680 228643681 228643682 228670569 228670571 228670572 228670684 228670686 228670687 228670688 228700237 228718675 228718676 228718677 228718678 228718679 228718680 228718683 228718684 228718685 228737493 228737494 228783460 228783462 228783463 228783464 228858946 228858947 228858948 228858949 228858950 228858951 228858952 228859334 228859335 228859336 228859337 228914036 228914037 228914038 228914039 228914040 228914041 228914042 228914043 228914044 228957881 228957883 228957884 228957885 228957886 228957887 229010921 229010922 229010923 229049855 229049856 229049857 229049858 229049859 229101102 229101103 229101104 229101105 229101106 229101107 229101108 229127589 229127592 229142583 229142584 229142585 229143306 229190409 46705 SYSTEM 46705 EXACTA DRAINAGE 100ML UDI-DI/GTIN code: 00763000333706 Lot Numbers: 219390372 219395752 220051766 220156498 220236202 220244366 220453468 220461215 221158924 221262136 221525914 221827837 221916511 221916669 221922073 221952419 221952420 221955178 222277588 222277589 222595124 222595125 222601683 222629818 222658829 222695532 222724804 222742119 222810785 223130640 223165959 223833463 223833464 223833727 223878399 224277484 224277485 224277826 224277827 224303369 224303370 224303371 224303372 224342502 224438297 224438298 224471869 224471870 224515879 225198814 225198815 225234347 225234348 225271661 225271662 225336433 225336434 225375786 225375787 225412024 225422434 225422435 225631429 225675934 225726234 225727012 225727014 225727015 225837239 225837240 225885117 225885118 225885119 226366017 226366018 227137137 227137138 227194733 227194734 227307881 227307882 227307883 227307884 227307885 227420343 227490793 227585336 227585337 227726341 227726342 227726343 227726344 227779119 227843362 228081284 228123262
Recalling Firm/
Manufacturer
Medtronic Neurosurgery
4620 North Beach Street
Fort Worth TX 76137
For Additional Information ContactRita 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 2
Under Investigation by firm
ActionOn 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 Commerce258,367 units
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = GWM
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