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U.S. Department of Health and Human Services

Class 1 Device Recall Pipeline Flex with Shield Technology

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  Class 1 Device Recall Pipeline Flex with Shield Technology see related information
Date Initiated by Firm February 14, 2020
Date Posted March 09, 2020
Recall Status1 Terminated 3 on June 12, 2024
Recall Number Z-1528-2020
Recall Event ID 85069
Product Classification Intracranial aneurysm flow diverter - Product Code OUT
Product ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Code Information Lots: A918616 A918617 A918618 A918619 A918620 A918621 A918622 A918623 A918624 A918625 A918626 A918628 A918665 A918667 A918668 A920902 A922597 A922598 A922599 A922600 A922601 A922687 A922688 A922690 A922691 A922692 A922693 A922694 A922695 A922697 A922698 A922699 A925289 A925290 A925291 A925292 A925293 A925295 A925296 A925297 A925298 A925299 A925300 A925913 A925914 A925915 A925917 A925918 A925920 A925923 A925926 A925928 A925929 A925930 A925931 A926530 A926531 A926532 A926533 A926536 A926537 A926538 A926625 A926626 A926627 A926628 A926629 A927960 A927961 A927962 A931450 A931451 A931452 A931453 A931454 A931455 A931456 A931458 A931459 A931460 A934805 A934806 A934807 A934808 A934809 A935480 A935481 A935482 A935483 A935484 A935486 A935487 A935900 A935901 A935902 A935903 A935904 A935912 A935913 A935914 A935916 A935917 A936513 A936514 A936515 A936516 A936517 A936518 A936519 A936520 A936522 A936523 A936524 A937232 A937233 A937234 A937235 A937236 A937242 A937655 A938294 A938295 A938296 A938297 A938298 A938299 A938301 A939100 A939101 A939103 A939104 A939137 A939138 A939139 A939140 A939142 A939143 A939144 A939145 A939146 A939148 A939151 A939154 A939612 A939613 A939614 A939615 A939616 A939617 A939618 A939619 A939620 A939621 A939622 A939623 A939624 A939625 A939626 A939627 A939628 A939629 A939630 A939632 A941401 A941403 A941404 A941405 A941406 A941407 A941409 A941410 A941411 A941415 A941417 A942167 A942168 A943052 A943053 A943054 A943056 A943219 A943220 A943222 A943321 A943322 A943324 A943326 A943672 A943674 A943676 A943677 A943678 A943680 A943682 A943683 A943684 A943686 A945206 A945207 A945208 A945209 A945210 A946108 A946109 A946110 A946591 A946592 A948115 A948116 A948117 A948118 A948119 A948120 A948121 A948122 A950755 A950756 A950757 A950758 A950759 A950760 A950941 A950942 A950943 A950944 A952144 A952145 A952146 A952147 A952148 A952149 A952150 A952153 A952154 A952155 A952156 A952157 A952483 A952484 A952485 A952486 A952487 A952488 A952489 A952490 A952491 A952497 A952498 A952684 A952685 A952686 A952687 A952688 A952689 A952690 A952692 A952693 A952694 A952695 A952696 A952697 A953298 A953919 A953920 A953921 A953922 A953924 A953925 A953926 A953927 A953929 A953930 A954177 A954178 A954180 A954181 A954182 A954185 A954186 A954187 A954188 A954189 A954190 A954191 A954192 A954193 A954194 A954195 A954514 A954515 A954516 A954518 A954519 A954520 A954521 A954522 A954523 A954524 A954525 A954526 A954527 A954528 A954529 A954530 A954531 A954532 A954533 A954534 A954535 A954793 A954794 A954795 A954796 A954797 A954798 A954799 A954801 A954802 A954803 A954804 A954805 A954807 A954809 
Recalling Firm/
Micro Therapeutics Inc, Dba Ev3 Neurovascular
9775 Toledo Way
Irvine CA 92618-1811
Manufacturer Reason
for Recall
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
FDA Determined
Cause 2
Process change control
Action On 02/14/20, Medtronic mailed Urgent Medical Device Recall notices to Healthcare Professionals and Risk Managers. They were advised of the following: 1) Do not use any affected product. Remove and quarantine all unused affected products in your inventory. 2) Return the affected products. Medtronic representatives can assist with facilitating the return of affected product and with identifying suitable replacement product. 3) Complete and return the Customer Confirmation Form. In addition, customers were asked to share the communication within their organization, with other organizations where affected devices were transferred, and any other associated organizations that may be impacted. On 09/04/2020, a Safety and Labeling Notification was sent to customers informing them that that Instructions for Use will be supplemented to update the Precaution and Warning statements and the Device Complications section. Medtronic recommends that physician users be attentive to the updated information in the Instructions for Use and include this information in discussions with patients. Further, please share this communication within your organization, with other organizations where these devices have been transferred, and any other associated organizations that may be impacted by this action.
Quantity in Commerce 762
Distribution Worldwide distribution. US nationwide, Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon, Mexico, Netherlands, Norway, Paraguay, Poland, Qatar, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Viet Nam
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.