{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "95518", "product_res_number": "Z-0428-2011", "event_date_initiated": "2010-10-25", "event_date_posted": "2010-11-24", "recall_status": "Terminated", "event_date_terminated": "2011-06-01", "res_event_number": "57166", "product_code": "NRY", "k_numbers": [ "K072718" ], "product_description": "Penumbra System Reperfusion Catheter 032, catalog number PSC032, lot number lot F15020, manufactured by Penumbra, Alameda, CA.", "code_info": "Lot number F15020", "firm_fei_number": "3005168196", "recalling_firm": "Penumbra Inc.", "address_1": "1351 Harbor Bay Pkwy", "city": "Alameda", "state": "CA", "postal_code": "94502-6541", "additional_info_contact": "510-748-3200", "reason_for_recall": "Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment.", "root_cause_description": "Process control", "action": "Penumbra issued an Urgent Voluntary Field Removal letter dated October 28, 2010 to consignees, identifying the affected device and actions to be taken by consignees. Customers were instructed to inspect their inventory for the affected product and quarantine it, pending return to Penumbra. Penumbra employees will contact customers to arrange return and replacement of affected units. \nCustomers were also requested to complete and return a product identification form and return form to Penumbra within 5 business days.\nCustomers can contact Penumbra at 1 510 748-3223 concerning this action.", "product_quantity": "61", "distribution_pattern": "Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.", "openfda": { "k_number": [ "K190338", "K033736", "K161640", "K191946", "K230429", "K160449", "K260002", "K172448", "K230695", "K173761", "K113163", "K243287", "K182101", "K243601", "K211411", "K173841", "K142458", "K153071", "K242104", "K100769", "K063774", "K203592", "K062046", "K242672", "K190212", "K133317", "K233988", "K180008", "K222786", "K061059", "K071172", "K250958", "K253590", "K162901", "K141491", "K254276", "K223530", "K252046", "K202251", "K251015", "K212908", "K250012", "K090085", "K252707", "K072718", "K211120", "K150616", "K232524", "K201689", "K210996", "K243047", "K253062", "K181354", "K161064", "K191768", "K211338", "K251789", "K183464", "K232971", "K251357", "K250690", "K133464", "K173200", "K190010", "K183185", "K161879", "K180705", "K141516", "K211476", "K093610", "K234083", "K081305", "K222808", "K132641", "K120961", "K090752", "K160641", "K223545", "K202182", "K123378", "K151623", "K251603", "K182522", "K183043", "K173452", "K251828", "K070521", "K190464", "K152541", "K122478", "K242504", "K240917", "K143077", "K220808", "K172167", "K082034", "K211654", "K223913", "K233329", "K251006", "K243948", "K203440", "K193380", "K252392", "K193063", "K113455", "K221934", "K243080", "K241221", "K211697" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2", "registration_number": [ "3013556777", "3014211783", "3022392708", "3002807314", "3007007790", "3021009035", "1220477", "3031288142", "3014590708", "3030088112", "3008853977", "3020954126", "1721676", "2024311", "3003144120", "2011171", "3007628272", "3010034260", "3021520400", "3005168196", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "9616664", "3009380063", "3014644549", "3010079067", "3012931345", "3017168767", "3015453963", "3006451981", "2030624", "3009957947", "3015531723", "3016678045", "3008881809", "3011370111", "2183744", "3039020025", "3012497308", "3015615738", "3015550451", "1721504", "3009337401", "3014498720", "3019807891", "3016540856", "3014162263", "3008264254", "2183828", "3008824097", "3008114965", "3013656790", "2029214", "3014590707", "3016591327", "3015701715" ], "fei_number": [ "3013556777", "3004099094", "3014211783", "3002807314", "3007007790", "3022392708", "3021009035", "1220477", "3031288142", "3014590708", "3030088112", "3008853977", "3020954126", "1721676", "2024311", "2011171", "3007628272", "3010034260", "3021520400", "3005168196", "1000220862", "3012543881", "3013758550", "3008837339", "1048735", "3009546466", "3016522967", "3009380063", "3014644549", "3010079067", "3012931345", "3017168767", "3015453963", "3006451981", "3009957947", "3015531723", "3016678045", "3008881809", "3011370111", "2183744", "3039020025", "3012497308", "3015615738", "3015550451", "1721504", "3009337401", "3014498720", "3019807891", "3016540856", "3014162263", "3008264254", "2183828", "3008824097", "3008114965", "3013656790", "3014590707", "3016591327", "3009024869", "3000206435", "3015701715" ] } } ] }