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U.S. Department of Health and Human Services

Class 1 Device Recall Pipeline" Flex Embolization Device, Pipeline" Flex Embolization Device with Shield Technology"

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  Class 1 Device Recall Pipeline" Flex Embolization Device, Pipeline" Flex Embolization Device with Shield Technology" see related information
Date Initiated by Firm July 13, 2021
Create Date September 03, 2021
Recall Status1 Open3, Classified
Recall Number Z-2403-2021
Recall Event ID 88447
PMA Number P100018 
Product Classification Intracranial aneurysm flow diverter - Product Code OUT
Product EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Code Information Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390 A849720  Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-14 00847536002043 Lot Numbers: A812725 A832008 A833123 A846924  Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-16 00847536002050 Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927  Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-20 00847536002074 Lot Numbers: A810946 A816343 A816343 A819116  Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-12 00847536002098 Lot Number: A916293  Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-14 00847536002104 Lot Numbers: A830303 A830304 A846930 A846931  Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-16 00847536002111 Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194  Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-18 00847536002128 Lot Numbers: A810946 A821512 A836546 A849721  Product/REF/UDI: PED2-275-20 PIPELINE FLEX SHIELD PED2-275-20 00847536002135 Lot Numbers: A827600 A842691  Product/REF/UDI: PED2-300-10 PIPELINE FLEX SHIELD PED2-300-10 00847536002142 Lot Numbers: A833123 A836549  Product/REF/UDI: PED2-300-12 PIPELINE FLEX SHIELD PED2-300-12 00847536002159 Lot Number: A821514  Product/REF/UDI: PED2-300-14 PIPELINE FLEX SHIELD PED2-300-14 00847536002166 Lot Numbers: A818298 A916294  Product/REF/UDI: PED2-300-16 PIPELINE FLEX SHIELD PED2-300-16 00847536002173 Lot Numbers: A826275 A830766 A834391 A846933  Product/REF/UDI: PED2-300-18 PIPELINE FLEX SHIELD PED2-300-18 00847536002180 Lot Numbers: A818299 A827602 A836550 A842691 A847555  Product/REF/UDI: PED2-300-20 PIPELINE FLEX SHIELD PED2-300-20 00847536002197 Lot Number: A916295  Product/REF/UDI: PED2-300-25 PIPELINE FLEX SHIELD PED2-300-25 00847536002685 Lot Numbers: A818459 A826923 A829033 A848678  Product/REF/UDI: PED2-300-30 PIPELINE FLEX SHIELD PED2-300-30 00847536002692 Lot Numbers: A829034 A848679  Product/REF/UDI: PED2-300-35 PIPELINE FLEX SHIELD PED2-300-35 00847536002708 Lot Number: A822215  Product/REF/UDI: PED2-325-10 PIPELINE FLEX SHIELD PED2-325-10 00847536002203 Lot Numbers: A817764 A827602 A847556  Product/REF/UDI: PED2-325-14 PIPELINE FLEX SHIELD PED2-325-14 00847536002227 Lot Numbers: A832011 A832016  Product/REF/UDI: PED2-325-16 PIPELINE FLEX SHIELD PED2-325-16 00847536002234 Lot Numbers: A833044 A833700 A834393  Product/REF/UDI: PED2-325-18 PIPELINE FLEX SHIELD PED2-325-18 00847536002241 Lot Numbers: A830768 A832012 A833701  Product/REF/UDI: PED2-325-20 PIPELINE FLEX SHIELD PED2-325-20 00847536002258 Lot Numbers: A817764 A821515 A821517 A830770 A833702  Product/REF/UDI: PED2-325-25 PIPELINE FLEX SHIELD PED2-325-25 00847536002715 Lot Number: A843367  Product/REF/UDI: PED2-325-30 PIPELINE FLEX SHIELD PED2-325-30 00847536002722 Lot Numbers: A829036 A837012  Product/REF/UDI: PED2-325-35 PIPELINE FLEX SHIELD PED2-325-35 00847536002739 Lot Numbers: A812734 A818460 A822627  Product/REF/UDI: PED2-350-12 PIPELINE FLEX SHIELD PED2-350-12 00847536002272 Lot Number: A819136  Product/REF/UDI: PED2-350-14 PIPELINE FLEX SHIELD PED2-350-14 00847536002289 Lot Numbers: A816345 A816346 A817765 A830771 A830772 A847557 A847558  Product/REF/UDI: PED2-350-16 PIPELINE FLEX SHIELD PED2-350-16 00847536002296 Lot Numbers: A821519 A826276 A827603 A833703 A833704 A838752 A838754 A847559 A852253 A861606  Product/REF/UDI: PED2-350-18 PIPELINE FLEX SHIELD PED2-350-18 00847536002302 Lot Numbers: A811477 A819168 A821521 A833706 A834396 A849722 A864469 A864470 A900741 A900742 A902096 A902097 A906054  Product/REF/UDI: PED2-350-20 PIPELINE FLEX SHIELD PED2-350-20 00847536002319 Lot Numbers: A815075 A816346 A819169 A822208 A838755 A855392 A870618 A871636 A898546 A900744  Product/REF/UDI: PED2-350-25 PIPELINE FLEX SHIELD PED2-350-25 00847536002746 Lot Numbers: A822630 A830777 A837014 A843368 A848680 A861757 A917150  Product/REF/UDI: PED2-350-30 PIPELINE FLEX SHIELD PED2-350-30 00847536002753 Lot Numbers: A813318 A817116 A818461 A826924  Product/REF/UDI: PED2-350-35 PIPELINE FLEX SHIELD PED2-350-35 00847536002760 Lot Numbers: A817117 A822664 A829037 A838762 A848680 A848681 A861758  Product/REF/UDI: PED2-375-10 PIPELINE FLEX SHIELD PED2-375-10 00847536002326 Lot Numbers: A855393 A859750 A871637 A873195 A903562  Product/REF/UDI: PED2-375-12 PIPELINE FLEX SHIELD PED2-375-12 00847536002333 Lot Numbers: A866016 A887303  Product/REF/UDI: PED2-375-14 PIPELINE FLEX SHIELD PED2-375-14 00847536002340 Lot Numbers: A836551 A838756 A861607  Product/REF/UDI: PED2-375-16 PIPELINE FLEX SHIELD PED2-375-16 00847536002357 Lot Numbers: A817766 A827605 A838757 A838758 A861608 A914211  Product/REF/UDI: PED2-375-18 PIPELINE FLEX SHIELD PED2-375-18 00847536002364 Lot Numbers: A812726 A819170 A822209 A834397 A834398 A835004 A849723 A849724 A849725 A871637 A884594 A889028 A890630 A894603  Product/REF/UDI: PED2-375-20 PIPELINE FLEX SHIELD PED2-375-20 00847536002371 Lot Numbers: A835005 A849731 A866017 A881420 A884598 A894604  Product/REF/UDI: PED2-375-25 PIPELINE FLEX SHIELD PED2-375-25 00847536002777 Lot Numbers: A822666 A822667 A832013 A843371 A867847 A869092 A882136 A885864 A887303  Product/REF/UDI: PED2-375-30 PIPELINE FLEX SHIELD PED2-375-30 00847536002784 Lot Numbers: A822668 A837015 A848681 A849905 A867210  Product/REF/UDI: PED2-375-35 PIPELINE FLEX SHIELD PED2-375-35 00847536002791 Lot Numbers: A813318 A818462 A822669 A862921 A870625  Product/REF/UDI: PED2-400-10 PIPELINE FLEX SHIELD PED2-400-10 00847536002388 Lot Number: A882122  Product/REF/UDI: PED2-400-12 PIPELINE FLEX SHIELD PED2-400-12 00847536002395 Lot Numbers: A810946 A852254 A856756 A856757 A859751 A871639 A904258 A904873 A916296  Product/REF/UDI: PED2-400-14 PIPELINE FLEX SHIELD PED2-400-14 00847536002401 Lot Numbers: A856757 A859752 A870618 A871640  Product/REF/UDI: PED2-400-16 PIPELINE FLEX SHIELD PED2-400-16 00847536002418 Lot Numbers: A812727 A812728 A822210 A822210 A830774 A836552 A847560 A849731 A849731 A861609 A861756 A864472 A864474 A865236 A865239 A871933 A882134 A903563 A904237 A904239 A904875 A904876 A916297 A916298 A916299  Product/REF/UDI: PED2-400-18 PIPELINE FLEX SHIELD PED2-400-18 00847536002425 Lot Numbers: A811477 A812729 A812730 A812731 A815076 A827606 A833045 A833046 A833707 A833709 A833710 A836553 A836554 A847561 A847562 A847563 A847564 A847565 A847635 A849732 A849733 A849891 A852255 A864475 A864476 A865240 A865241 A882135  Product/REF/UDI: PED2-400-20 PIPELINE FLEX SHIELD PED2-400-20 00847536002432 Lot Numbers: A811477 A815077 A815078 A815078 A815079 A815080 A815080 A827607 A833105 A833107 A836555 A836555 A847636 A847637 A849892 A849893 A849895 A852256 A864477 A864480 A864482 A865242 A866003 A903567 A916300 A917147 A917148 A918062 A918063 A918069  Product/REF/UDI: PED2-400-25 PIPELINE FLEX SHIELD PED2-400-25 00847536002807 Lot Numbers: A829039 A833712 A843371 A848720 A848722 A858335 A858337 A861758 A871935 A873200 A903566 A904232 A904241 A904906  Product/REF/UDI: PED2-400-30 PIPELINE FLEX SHIELD PED2-400-30 00847536002814 Lot Numbers: A822670 A822671 A830778 A833115 A837018 A843372 A858340 A871936  Product/REF/UDI: PED2-400-35 PIPELINE FLEX SHIELD PED2-400-35 00847536002821 Lot Numbers: A826925 A829042 A835012 A837019 A843372 A843374 A849906  Product/REF/UDI: PED2-425-10 PIPELINE FLEX SHIELD PED2-425-10 00847536002449 Lot Numbers: A811477 A816346  Product/REF/UDI: PED2-425-12 PIPELINE FLEX SHIELD PED2-425-12 00847536002456 Lot Numbers: A811477 A816347  Product/REF/UDI: PED2-425-14 PIPELINE FLEX SHIELD PED2-425-14 00847536002463 Lot Numbers: A838759 A871955  Product/REF/UDI: PED2-425-16 PIPELINE FLEX SHIELD PED2-425-16 00847536002470 Lot Numbers: A811477 A816348 A826462 A830774 A842691 A842691 A842692 A848260 A902098 A902098  Product/REF/UDI: PED2-425-18 PIPELINE FLEX SHIELD PED2-425-18 00847536002487 A816349 A817106 A826463 A827608 A869091 A898549 A900745  Product/REF/UDI: PED2-425-20 PIPELINE FLEX SHIELD PED2-425-20 00847536002494 Lot Numbers: A815080 A817107 A817108 A826464 A827609 A828614 A848261 A898549 A898551  Product/REF/UDI: PED2-425-25 PIPELINE FLEX SHIELD PED2-425-25 00847536002838 Lot Numbers: A813319 A815694 A839454 A839455 A843374 A843374 A898557 A898558  Product/REF/UDI: PED2-425-30 PIPELINE FLEX SHIELD PED2-425-30 00847536002845 Lot Numbers: A822673 A822938 A822939 A822941 A839456 A843374 A918068  Product/REF/UDI: PED2-425-35 PIPELINE FLEX SHIELD PED2-425-35 00847536002852 Lot Numbers: A822942 A839459 A839463 A839466  Product/REF/UDI: PED2-450-10 PIPELINE FLEX SHIELD PED2-450-10 00847536002500 Lot Numbers: A817767 A918065  Product/REF/UDI: PED2-450-12 PIPELINE FLEX SHIELD PED2-450-12 00847536002517 Lot Numbers: A849896 A859753 A862918 A871933 A873197 A904253  Product/REF/UDI: PED2-450-14 PIPELINE FLEX SHIELD PED2-450-14 00847536002524 Lot Numbers: A862919 A866018 A866019 A870621  Product/REF/UDI: PED2-450-16 PIPELINE FLEX SHIELD PED2-450-16 00847536002531 Lot Numbers: A815080 A822210 A826464 A828615 A842693 A842694 A848262 A849897 A852720 A852721 A854046 A855394 A858331 A868555 A868564 A869091 A894605  Product/REF/UDI: PED2-450-18 PIPELINE FLEX SHIELD PED2-450-18 00847536002548 Lot Numbers: A811479 A815080 A822211 A826465 A828616 A833109 A842695 A848263 A854048 A858332 A858334 A859754 A859755 A867846 A868565 A871934 A871935 A894606 A918066  Product/REF/UDI: PED2-450-20 PIPELINE FLEX SHIELD PED2-450-20 00847536002555 Lot Numbers: A811480 A815080 A815080 A815080 A815080 A815691 A817109 A817110 A817769 A818290 A833111 A866021 A866023 A866025 A868566 A869091 A890631 A897350 A897354 A897358 A903543  Product/REF/UDI: PED2-450-25 PIPELINE FLEX SHIELD PED2-450-25 00847536002869 Lot Numbers: A815695 A815696 A826926 A826926 A829043 A830779 A839468 A843374 A843375 A852256 A854050 A858341 A858342 A861759 A894607 A896157 A918070  Product/REF/UDI: PED2-450-30 PIPELINE FLEX SHIELD PED2-450-30 00847536002876 Lot Numbers: A822943 A826926 A839471 A843376 A843376 A852257 A854051 A854052 A856680 A858343 A864484 A866004 A899364  Product/REF/UDI: PED2-450-35 PIPELINE FLEX SHIELD PED2-450-35 00847536002883 Lot Numbers: A839474 A839878 A854055 A854056 A854061 A869085  Product/REF/UDI: PED2-475-12 PIPELINE FLEX SHIELD PED2-475-12 00847536002579 Lot Numbers: A826465 A885863  Product/REF/UDI: PED2-475-14 PIPELINE FLEX SHIELD PED2-475-14 00847536002586 Lot Numbers: A822212 A854049 A855395 A873198 A903566  Product/REF/UDI: PED2-475-16 PIPELINE FLEX SHIELD PED2-475-16 00847536002593 Lot Numbers: A815692 A828617 A835008 A842696 A848660 A848661 A889029 A898552 A904230  Product/REF/UDI: PED2-475-18 PIPELINE FLEX SHIELD PED2-475-18 00847536002609 Lot Numbers: A812732 A819171 A833711 A835009 A837011 A838760 A849898 A849898 A849904 A878855 A878856 A899361  Product/REF/UDI: PED2-475-20 PIPELINE FLEX SHIELD PED2-475-20 00847536002616 Lot Numbers: A812733 A817110 A817111 A817112 A826466 A826467 A826919 A826920 A828618 A866412 A867208 A869083 A885863 A894159 A898555 A900746 A900747 A900749 A902100  Product/REF/UDI: PED2-475-25 PIPELINE FLEX SHIELD PED2-475-25 00847536002890 Lot Numbers: A813320 A822944 A822945 A830780 A833117 A835014 A837020 A843378 A848723 A848724 A900750  Product/REF/UDI: PED2-475-30 PIPELINE FLEX SHIELD PED2-475-30 00847536002906 Lot Numbers: A815697 A817117 A819203 A826926 A833119 A835015 A835018 A848724 A852543 A869085 A900752 A902101  Product/REF/UDI: PED2-475-35 PIPELINE EMB DEVICE PED2-475-35 00847536002913 Lot Numbers: A833713 A833714 A833715 A835019 A848724 A849911 A850777 A879717 A879718 A879719  Product/REF/UDI: PED2-500-12 PIPELINE FLEX SHIELD PED2-500-12 00847536002630 Lot Numbers: A812095 A818300 A819172  Product/REF/UDI: PED2-500-14 PIPELINE FLEX SHIELD PED2-500-14 00847536002647 Lot Numbers: A812733 A818301 A822213  Product/REF/UDI: PED2-500-16 PIPELINE FLEX SHIELD PED2-500-16 00847536002654 Lot Numbers: A822213 A833113 A867209 A868567  Product/REF/UDI: PED2-500-18 PIPELINE FLEX SHIELD PED2-500-18 00847536002661 Lot Numbers: A822215 A829030 A830775 A838761 A848676 A848677 A897361 A899362  Product/REF/UDI: PED2-500-20 PIPELINE FLEX SHIELD PED2-500-20 00847536002678 Lot Numbers: A815693 A817113 A817115 A826921 A826921 A826922 A829031 A830776 A833114 A835010 A862920 A889033 A894607 A896155 A896155 A897363 A897365  Product/REF/UDI: PED2-500-25 PIPELINE FLEX SHIELD PED2-500-25 00847536002920 Lot Numbers: A822946 A826927 A830781 A835020 A837021 A837022 A897367 A897369  Product/REF/UDI: PED2-500-35 PIPELINE EMB DEVICE PED2-500-35 00847536002944 Lot Numbers: A822947 A839879 A873200 A899368 A903564 B005844 
Recalling Firm/
Manufacturer		 Micro Therapeutics Inc,
9775 Toledo Way
Irvine CA 92618-1811
For Additional Information Contact David Young
508-4521644
Manufacturer Reason
for Recall		 Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.
FDA Determined
Cause 2		 Device Design
Action On 07/13/2021, the firm sent via mail courier service an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customer informing them they have received reports of serious injuries and deaths in connection with delivery pushwire fracture at the distal section of the delivery system during use. This recall affects all models of the embolization devices manufactured between April - October 2019, and April - May 2020. Customers are instructed to: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted products in their inventory. 2. Return the impacted products to the Recalling Firm. Their Recalling Firm representative can assist in facilitating the return of product as necessary. If alternative product is needed, their Recalling Firm representative can assist them with identifying suitable replacement product. 3. Complete the attached Customer Confirmation Form, see Attachment 2, and fax it to 1-651-367-7075 to the attention of Neurovascular Quality or email it to rs.navfca@medtronic.com. 4. Share this communication within their organization, with other organizations where impacted devices may have been transferred, and any other associated organizations that may be impacted by this action. For additional questions and/or assistance, contact the Recalling Firm's Representative or email the Office of Medical Affairs at rs.nvoma@medtronic.com.
Quantity in Commerce 16,169 total devices for all model/products
Distribution U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.
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.
PMA Database PMAs with Product Code = OUT and Original Applicant = Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR
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