| Class 1 Device Recall Exacta External Drainage and Monitoring System |  |
Date Initiated by Firm | November 01, 2024 |
Date Posted | December 19, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0662-2025 |
Recall Event ID |
95725 |
510(K)Number | K200456 |
Product Classification |
Device, monitoring, intracranial pressure - Product Code GWM
|
Product | 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). |
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
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220315154
221133364
221303416
221687758
221860411
222083287
222163798
222204316
222658830
222810946
223027466
223052246
223070520
223070521
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223255543
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225631426
226111270
226111271
226366028
226516611
226516612
226516613
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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
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46705 SYSTEM 46705 EXACTA DRAINAGE 100ML
UDI-DI/GTIN code: 00763000333706
Lot Numbers:
219390372
219395752
220051766
220156498
220236202
220244366
220453468
220461215
221158924
221262136
221525914
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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 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 2 | 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 | 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, 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 |
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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.
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510(K) Database | 510(K)s with Product Code = GWM
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