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U.S. Department of Health and Human Services

Class 1 Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device

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  Class 1 Device Recall MINDFRAME CAPTURE(TM) LP Revascularization Device see related information
Date Initiated by Firm February 26, 2018
Date Posted May 16, 2018
Recall Status1 Terminated 3 on September 30, 2021
Recall Number Z-1701-2018
Recall Event ID 79463
510(K)Number K141516  
Product Classification Catheter, thrombus retriever - Product Code NRY
Product MindFrame Capture LP Revascularization Devices: Product Numbers:
(a) REF 300010
(b) REF 300011
(c) REF 300012
(d) REF 300013
(e) REF 300014
(f) REF 300015
(g) REF 300016
(h) REF 300017
(i) REF 300018

Intended to restore blood flow by removing thrombus from a large intracranial vessel experiencing ischemic stroke within 8 hours of symptom onset.
Code Information All lot numbers: Product Number: UDI (a) REF 300010: 00843889031334, 00843889031341, 00847536020207 (b) REF 300011: 00843889031365, 00843889031372, 00847536020214 (c) REF 300012: 00843889031396, 00843889031402, 00847536020221 (d) REF 300013: 00843889031426, 00843889031433, 00847536020238 (e) REF 300014: NOT DISTRIBUTED (f) REF 300015: 00847536020122, 00847536020160 (g) REF 300016: 00847536020139, 00847536020177 (h) REF 300017: 00847536020146, 00847536020184 (i) REF 300018: 00847536020153, 00847536020191 
Recalling Firm/
Manufacturer		 Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact Mr. Chirag Tilara
949-680-1305
Manufacturer Reason
for Recall		 There is a potential issue for all MindFrame Capture devices to partially detach or separate from the delivery wire.
FDA Determined
Cause 2		 Process design
Action The firm initiated their recall via an Urgent Medical Device Recall letter, dated February 26, 2018. The letter identified the affected device, described the issue, product scope, and the actions to be taken. The firm recommended users remove and quarantine all affected and unexpired product in their inventory and return the affected products to Medtronic. Customers may contact their Medtronic representative if alternative product is needed. The Customer Confirmation Form should be completed and faxed to Medtronic at 1-949-434-5020, to the attention of Neurovascular Quality.
Quantity in Commerce 1,942 units
Distribution Worldwide Distribution
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NRY and Original Applicant = MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
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