{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "185202", "product_res_number": "Z-0849-2021", "event_date_initiated": "2020-12-15", "event_date_posted": "2021-01-18", "recall_status": "Terminated", "event_date_terminated": "2024-05-14", "res_event_number": "86989", "product_code": "NRY", "k_numbers": [ "K190010", "K191946", "K202251" ], "product_description": "Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT\n\n The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems.", "code_info": "Product Name: Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing Catalog Number: 5MAXJET7KIT UDI Code: 00815948020962  Lot Number Range: C15441 thru C19176 F88882 thru F100278", "firm_fei_number": "3005168196", "recalling_firm": "Penumbra Inc.", "address_1": "1 Penumbra 1", "city": "Penumbra Alameda", "state": "CA", "postal_code": "94502-7610", "additional_info_contact": "Gita Barry\n510-748-3200", "reason_for_recall": "The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.", "root_cause_description": "Process design", "action": "On 12/15/2020, the firm posted a press release (https://www.penumbrainc.com/wp-content/uploads/2020/12/JET-7XF-15Dec20.pdf) and issued an \"URGENT VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION\" letter via FedEx informing customers that all configurations of their reperfusion catheters may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization or contrast injection may result in potential vessel damage, and subsequent patient injury or death.\n\nCustomers are instructed to:\n1.\tShare this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. \n2.\tImmediately review your inventory for the specific catalog numbers listed above. \n3.\tRemove all units from inventory and place them in quarantine for return to Penumbra, Inc.\n4.\tComplete and return the attached product identification / return form within 3 business days.\n5. Continue to report adverse events and quality problems experienced with the use of this product. Adverse events and quality problems may be reported to FDA s MedWatch Adverse Event Reporting Program either online, by regular mail, or by fax. For more information, please see https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.\n\nThe Recalling Firm will contact customers directly to arrange return of affected units and replace/refund returned product.\n\nIf customers have any questions or concerns, they can contact the Recalling Firm's Customer Service (order@penumbrainc.com or 1.888.272.4606), available Monday - Friday 7:30 AM to 4:00 PM PST, or their sales representative.", "product_quantity": "27,499 catheters", "distribution_pattern": "Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.", "openfda": { "k_number": [ "K152541", "K093610", "K191768", "K252707", "K250958", "K221934", "K243601", "K162901", "K201689", "K211411", "K071172", "K033736", "K234083", "K262399", "K062046", "K222808", "K211697", "K120961", "K113455", "K180008", "K133317", "K230429", "K212908", "K211338", "K253590", "K250012", "K233329", "K160641", "K223530", "K262398", "K251357", "K191946", "K183464", "K252392", "K243287", "K141516", "K193063", "K133464", "K250690", "K173200", "K242672", "K150616", "K143077", "K160449", "K203440", "K151623", "K142458", "K172167", "K181354", "K090752", "K122478", "K063774", "K211476", "K061059", "K153071", "K173452", "K182101", "K232971", "K243948", "K183185", "K242104", "K161640", "K161064", "K223545", "K132641", "K242504", "K223913", "K123378", "K241221", "K202251", "K173761", "K180705", "K251789", "K161879", "K243047", "K172448", "K262391", "K232524", "K090085", "K233988", "K070521", "K072718", "K190464", "K253062", "K222786", "K251828", "K243080", "K254276", "K251603", "K252046", "K260002", "K081305", "K251006", "K202182", "K203592", "K173841", "K220808", "K141491", "K230695", "K211654", "K240917", "K193380", "K190010", "K190212", "K211120", "K082034", "K182522", "K210996", "K183043", "K113163", "K251015", "K190338", "K100769" ], "registration_number": [ "3012543881", "3015453963", "3013758550", "3021009035", "2011171", "3010079067", "2024311", "3019807891", "3008264254", "3008853977", "3016540856", "3008824097", "3017168767", "3013556777", "3009957947", "3007007790", "3013656790", "3003144120", "3008881809", "1048735", "3012497308", "3012931345", "3039020025", "1721504", "3015615738", "2183828", "3014644549", "1721676", "3014211783", "3009337401", "3011370111", "3015550451", "2183744", "3014162263", "3008114965", "2029214", "3015701715", "3009546466", "3031288142", "3006451981", "3016678045", "9616664", "3021520400", "3022392708", "3005168196", "1220477", "3016591327", "2030624", "3002807314", "3014498720", "3030088112", "3009380063", "3007628272", "3010034260", "3014590707", "3014590708", "3008837339", "3016522967", "3020954126", "3015531723" ], "fei_number": [ "3012543881", "3015453963", "3013758550", "3021009035", "2011171", "3010079067", "3004099094", "2024311", "3019807891", "3008264254", "3008853977", "3016540856", "3008824097", "3017168767", "1000220862", "3013556777", "3009957947", "3009024869", "3007007790", "3013656790", "3008881809", "1048735", "3012497308", "3012931345", "3039020025", "1721504", "3015615738", "2183828", "3014644549", "1721676", "3014211783", "3009337401", "3011370111", "3015550451", "2183744", "3014162263", "3008114965", "3015701715", "3009546466", "3031288142", "3006451981", "3016678045", "3021520400", "3022392708", "3000206435", "1220477", "3005168196", "3016591327", "3002807314", "3014498720", "3030088112", "3009380063", "3007628272", "3010034260", "3014590707", "3014590708", "3008837339", "3016522967", "3020954126", "3015531723" ], "device_name": "Catheter, Thrombus Retriever", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1250", "device_class": "2" } } ] }