{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "189088", "product_res_number": "Z-2577-2021", "event_date_initiated": "2021-08-13", "event_date_posted": "2021-09-29", "recall_status": "Completed", "res_event_number": "88611", "product_code": "NRY", "k_numbers": [ "K183043", "K202182", "K210996" ], "product_description": "Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.", "code_info": "Affected Lots: \nV2014902, F2026201, F2026802, F2028801, F2028901, F2029501, F2029701, F2030801, F2031101, F2035301, F2032502, F2100802, F2101301, F2104102, F2108101, F2108801, F2109601, F2109701, F2111101, F2110601, F2112301, F2113004, F2112001", "firm_fei_number": "3014590708", "recalling_firm": "IMPERATIVE CARE INC", "address_1": "1359 Dell Ave", "city": "Campbell", "state": "CA", "postal_code": "95008-6609", "additional_info_contact": "Nora Hadding\n699-235-8155", "reason_for_recall": "There is a potential for distal end of catheters to fracture and become detached.", "root_cause_description": "Under Investigation by firm", "action": "On August 18, 2021 , Imperative Care issued a \"Urgent: Voluntary Medical Device Recall\" Notification to all affected healthcare facilities. In addition to informing consignees about the recalled product, Imperative Care ask consignees to take the following actions: \n\n1.\tShare this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. \n\n2.\tImmediately review your inventory for the specific lot numbers listed within the recall notification . \n\n3.\tRemove and quarantine all unused affected products in your inventory.\n \n4.\tReturn the potentially affected products to Imperative Care. Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary.\n \n5.\tIf replacement product is needed, your Imperative Care Sales Representative can assist you with identifying suitable replacement product. \n\n6.\tComplete the attached Customer Confirmation Certificate and contact your local Imperative Care Sales Representative. \n\n7. Please ensure that the attached Customer Acknowledgement Certificate is returned within 3 business days to acknowledge receipt within your Department/Facility. This may be a requirement within your healthcare organization. \n\n8. If you have any questions regarding this voluntary recall, please contact Imperative Care Customer Service at 1-408-502-7548, your Imperative Care Sales Representative, or email us at return@imperativecare.com.\n\n9. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.", "product_quantity": "3118 units", "distribution_pattern": "US nationwide distribution.", "openfda": { "k_number": [ "K113455", "K202251", "K251603", "K251789", "K193380", "K082034", "K123378", "K252046", "K182101", "K232524", "K070521", "K160449", "K191946", "K183185", "K202182", "K193063", "K252392", "K262399", "K243948", "K141491", "K211697", "K243047", "K172167", "K230429", "K143077", "K242504", "K242672", "K262391", "K233329", "K190212", "K173452", "K180705", "K133464", "K190010", "K063774", "K223545", "K133317", "K241221", "K260002", "K250012", "K211338", "K262398", "K220808", "K150616", "K093610", "K212908", "K153071", "K251357", "K162901", "K161640", "K240917", "K191768", "K242104", "K230695", "K211120", "K234083", "K190338", "K113163", "K211411", "K253590", "K203592", "K222808", "K061059", "K062046", "K254276", "K201689", "K251006", "K172448", "K223530", "K223913", "K251828", "K081305", "K251015", "K250958", "K233988", "K243601", "K203440", "K161064", "K211476", "K183464", "K090752", "K132641", "K173200", "K252707", "K183043", "K141516", "K142458", "K161879", "K190464", "K221934", "K151623", "K222786", "K181354", "K160641", "K100769", "K152541", "K122478", "K072718", "K180008", "K253062", "K243080", "K211654", "K033736", "K120961", "K210996", "K182522", "K243287", "K250690", "K232971", "K173761", "K173841", "K260617", "K071172", "K090085" ], "registration_number": [ "2183828", "3010034260", "3010079067", "3016591327", "3016678045", "3020954126", "3008837339", "2183744", "3015615738", "3017168767", "3005168196", "3002807314", "3013758550", "3019807891", "3015701715", "1721504", "3014644549", "9616664", "3009337401", "3031288142", "3016540856", "3021520400", "3009380063", "3039020025", "3008824097", "1048735", "3013656790", "3003144120", "3012931345", "1721676", "3011370111", "3008114965", "3008853977", "3009957947", "3014590708", "2024311", "3012497308", "2030624", "3008881809", "3015531723", "3022392708", "3007628272", "3013556777", "3014498720", "2029214", "1220477", "3012543881", "3021009035", "3016522967", "3030088112", "3006451981", "3015550451", "3009546466", "3007007790", "2011171", "3014590707", "3008264254", "3015453963", "3014211783", "3014162263" ], "fei_number": [ "3004099094", "2183828", "3010034260", "3010079067", "3016591327", "3016678045", "3020954126", "3009024869", "3008837339", "2183744", "3015615738", "3017168767", "3005168196", "3002807314", "3013758550", "3000206435", "1000220862", "3019807891", "3015701715", "1721504", "3014644549", "3009337401", "3031288142", "3016540856", "3021520400", "3009380063", "3039020025", "3008824097", "1048735", "3013656790", "3012931345", "1721676", "3011370111", "3008114965", "3008853977", "3009957947", "3014590708", "2024311", "3012497308", "3008881809", "3015531723", "3022392708", "3007628272", "3013556777", "3014498720", "1220477", "3021009035", "3012543881", "3016522967", "3030088112", "3006451981", "3015550451", "3009546466", "3007007790", "2011171", "3014590707", "3008264254", "3015453963", "3014211783", "3014162263" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }