{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "215649", "product_res_number": "Z-2550-2025", "event_date_initiated": "2025-08-18", "event_date_posted": "2025-09-11", "recall_status": "Open, Classified", "res_event_number": "97466", "product_code": "GEH", "k_numbers": [ "K234002" ], "product_description": "ICEfx Cryoablation System, portable helium-free desktop cryoablation unit, Material Numbers (UPN) FPRCH8000, FPRCH8000-02, H749396118000", "code_info": "FPRCH8000 UDI-DI: 00859019006370, Serial Numbers: ICP0305, ICP0369, ICP0338;\n\nFPRCH8000-02 UDI-DI: 00859019006417, Serial Numbers: 86643865, 108415728, 88589050, 108470986, 89392275, 108612524, 107799735, ICP0299, 107887794, 3779, 108254011, IF0096\n108312221, 104733618;\n\nH749396118000 UDI-DI: 00191506014995, Serial Numbers: 106066356, 107851990", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "763-494-1700", "reason_for_recall": "Certain desiccant tube subassemblies were built with end caps that were not correctly tightened.", "root_cause_description": "Process control", "action": "An Urgent Medical Device Correction dated 8/18/25 was sent to customers.\n\nCustomers should cease use of the systems listed in Table 1 and segregate them until a\nBoston Scientific representative has corrected this issue. A Boston Scientific Field Service\nEngineer will contact your facility to schedule the correction of your system.\n\nFor patients in whom an impacted device has already been used, there are no specific\nrecommendations beyond the local standard post-procedure care.\n\nIf you require additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.\n\nThe Acknowledgement Form enclosed with this product correction must be completed and\nreturned even if you do not have any affected units.\n\nAn Urgent Medical Device Removal notification letter dated 8/18/25 was sent to a customer regarding the PM Kit ICEFX.\n\nInstructions:\n1. Further distribution or use of any devices (Table 1) affected by this removal should cease immediately.\nDo NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific.\n2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device.\n3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network.\n4. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions on page three.\n5. Return affected devices.\nIf you require additional\nassistance or more information regarding this communication, please contact your local\nBoston Scientific representative.", "product_quantity": "18 units", "distribution_pattern": "Worldwide - US Nationwide and the countries of Canada, France, Germany and Italy.\n\n(Preventive Maintenance Kit distributed to Canada only.)", "openfda": { "k_number": [ "K070893", "K243454", "K030303", "K151041", "K112072", "K973686", "K261806", "K242803", "K210529", "K954872", "K251524", "K842959", "K031117", "K172041", "K880416", "K970995", "K031697", "K181741", "K172769", "K803311", "K172049", "K972662", "K002615", "K252198", "K062175", "K760742", "K070482", "K193619", "K051509", "K961219", "K251928", "K203024", "K152203", "K223369", "K062896", "K073533", "K121507", "K012214", "K181153", "K904421", "K141485", "K991122", "K060859", "K111859", "K243245", "K003065", "K222356", "K240892", "K832334", "K980670", "K993965", "K190747", "K061510", "K935010", "K024009", "K091721", "K082074", "K041783", "K101049", "K102006", "K243042", "K052259", "K113860", "K260377", "K021261", "K892237", "K760953", "K233347", "K872796", "K882568", "K152668", "K161296", "K210310", "K991792", "K143564", "K203481", "K240776", "K844246", "K161557", "K153489", "K201183", "K163244", "K190407", "K231661", "K922878", "K151054", "K971392", "K242932", "K914591", "K781956", "K161337", "K944221", "K232635", "K964047", "K234002", "K110946", "K840536", "K212814", "K182392", "K934261", "K971216", "K964971", "K060144", "K150920", "K011950", "K162608", "K261068", "K121251", "K072883", "K251493", "K982358", "K882963", "K832385", "K891282", "K023487", "K011073", "K151309", "K060928", "K060279", "K180137", "K910491", "K160994", "K171522", "K190194", "K211149", "K772232", "K130995", "K252903", "K183213", "K970992", "K060390", "K172373", "K161202", "K020605", "K032271", "K090978", "K110754", "K052530", "K113021", "K193665", "K140058", "K152329", "K242625", "K140584", "K882962", "K162599", "K030838", "K982280", "K011708", "K924114", "K926464", "K111042", "K170810", "K881349", "K160669", "K083493", "K912529", "K230551", "K810409", "K201588", "K173037", "K141110", "K240457", "K896724", "K142441", "K854767", "K201366", "K953637", "K003811", "K153541", "K253348", "K982055", "K151968", "K253230", "K800335", "K171398", "K953294", "K771320", "K940140", "K050347", "K051052", "K760686", "K243487", "K060555", "K933327", "K963826", "K222272", "K201260", "K842704", "K911420", "K010991", "K190356", "K021211", "K980739", "K190651", "K242288", "K203032", "K991272", "K931299", "K162695", "K221234", "K130599", "K770058", "K133258", "K991517", "K101825", "K143625", "K140314", "K021387", "K052861", "K103310", "K171626", "K101333", "K760353", "K230271", "K002714", "K163684", "K942299", "K160273", "K040809", "K131523", "K813024", "K801921", "K011074", "K964336", "K023757", "K811390", "K032333", "K990877", "K955083", "K963970", "K161615", "K960387", "K042667", "K102360", "K221897", "K253000", "K183601", "K220674", "K954703", "K871314", "K072651", "K211099", "K240106", "K072453", "K201740", "K955011", "K152337", "K253114", "K262420", "K952895", "K022314", "K012497", "K982506", "K250742", "K980668", "K230599", "K152133", "K161480", "K161294", "K832140", "K123865", "K180211", "K980110" ], "registration_number": [ "1721504", "1526711", "1649518", "3010885402", "1047843", "3015521867", "3005369776", "3016832577", "2953359", "3012913237", "3008262715", "2521453", "1218813", "3017619652", "2024311", "3013445151", "3042940623", "9610614", "3008309062", "2937707", "3011706110", "3027153085", "3005740500", "1424263", "3015612252", "3013283620", "1222780", "3015351183", "2124215", "3016267994", "3030529508", "3013077751", "3033589330", "3014663814", "1216795", "1930126", "3020331900", "1450908", "3015733082", "3015967359", "1719513", "1724474", "1038758", "3013665681", "3015153469", "3007487007", "3016607092", "3022626486", "1216677", "3011307964", "3003678543", "3015309643", "3004087544", "3014635169", "3010242262", "3010684280", "1313700", "3015177815", "3010493171", "3010543854", "3012697079", "1720747", "9613249", "3016555232", "1417592", "3015224777", "1220477", "3017820152", "3010140265", "3009470597", "1528319", "3009719225", "1450662", "3039443404", "3008252257", "3008729892", "3003418325", "3004416964", "3015225571", "3008797959", "3009762450", "3010157088", "2518897", "3001675293", "3004215117", "3020164048", "3007829657", "1056356", "3011788769", "3013868968", "3011063460", "1811755", "2511556", "2134265", "3014144368", "3004608878", "3014527929", "3012187635", "9616793", "3004753330", "3002808022", "3004099264", "3006950086", "3015895145", "3008812068", "3012536737", "3015961134", "3039443708", "3012627460", "3026606306" ], "fei_number": [ "1721504", "3000215205", "1526711", "3010885402", "1047843", "3015521867", "3005369776", "3016832577", "3012913237", "3008262715", "2000004234", "2521453", "1218813", "3017619652", "2024311", "3042940623", "3002095335", "3008309062", "2937707", "3011706110", "3027153085", "3005740500", "3015612252", "3013283620", "3001236277", "3015351183", "2124215", "1000120743", "3030529508", "3013077751", "3033589330", "3014663814", "1216795", "1930126", "3020331900", "1450908", "3015733082", "3002807555", "3015967359", "1719513", "3012327827", "3002843919", "1038758", "3013665681", "1000208912", "3015153469", "3007487007", "3003094851", "3016607092", "3022626486", "1216677", "3011307964", "3003678543", "3015309643", "3004087544", "3014635169", "3010242262", "3010684280", "1313700", "3015177815", "3010493171", "3010543854", "1000140327", "1720747", "3016555232", "1417592", "3015224777", "1220477", "3017820152", "3010140265", "3009470597", "3002987034", "3009719225", "1450662", "3039443404", "3008252257", "3003015552", "1000080301", "3003418325", "3004416964", "3015225571", "3008797959", "3009762450", "3010157088", "3001675293", "3004215117", "3020164048", "3007829657", "3011788769", "3013868968", "1811755", "3011063460", "2511556", "3002806920", "3014144368", "3004608878", "3014527929", "3012187635", "3004753330", "3002808022", "3004099264", "3006950086", "3015895145", "3008812068", "3012536737", "3015961134", "3039443708", "3012627460", "1000122656", "3026606306" ], "device_name": "Unit, Cryosurgical, Accessories", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4350", "device_class": "2" } } ] }