{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Irvine",
      "state": "CA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88447",
      "recalling_firm": "Micro Therapeutics Inc,",
      "address_1": "9775 Toledo Way",
      "address_2": "N/A",
      "postal_code": "92618-1811",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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.",
      "recall_number": "Z-2403-2021",
      "product_description": "EV3 Pipeline Flex Embolization Device with Flex Shield Technology",
      "product_quantity": "16,169 total devices for all model/products",
      "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.",
      "recall_initiation_date": "20210713",
      "center_classification_date": "20210903",
      "report_date": "20210915",
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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 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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",
      "more_code_info": ""
    }
  ]
}