{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "178199", "product_res_number": "Z-0667-2020", "event_date_initiated": "2019-11-18", "event_date_created": "2019-12-11", "recall_status": "Terminated", "event_date_terminated": "2020-06-25", "res_event_number": "84375", "product_code": "JOS", "k_numbers": [ "K161305" ], "product_description": "Habib EUS RFA, 10mm electrode active tip, Material Number/UPN: 6500 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.", "code_info": "Material Number/UPN: 6500 GTIN: 5060271140725 Batches: 17-C02 (Expiration: 9-Jul-2020), 17-C06 (Expiration: 19-Feb-2021), 17-C07 (Expiration: 19-Feb-2021), 17-C08 (Expiration: 20-Feb-2021)", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "300 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1291", "additional_info_contact": "Nicole Pshon\n763-494-1556", "reason_for_recall": "During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the\nintroducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.", "root_cause_description": "Device Design", "action": "On November 18, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail stating:\nUrgent Medical Device Recall - Immediate Action Required\nHABIB\" EUS RFA 6500 and 6700\nDear Materials Manager / Field Action Contact:\nBoston Scientific (BSC) is initiating a voluntary removal of all HABIB\" EUS RFA devices that remain in distribution. BSC acquired EMcision in March 2018. EMcision was the manufacturer of the Habib EUS RFA devices subject to this recall. The EMcision UK entity is no longer operating, therefore BSC is initiating the action.\n\nBSC recently identified that these devices present a risk of energy transferring from the active tip to the introducer device which may result in thermal injury to tissue outside the intended treatment area. The most common injury anticipated is tissue damage requiring little or no medical intervention. There is a remote probability of tissue damage or perforation occurring as a result of this issue that may require medical intervention, however this has not been reported to date. There is no additional follow up recommended for patients treated with these devices beyond normal standard of care.\n\nThis recall affects all UPNs and batches listed below. No other products or UPNs are impacted by this notification. Refer to the Reply Verification Form included with this notification package for the list of individual batches we have record of shipping to your facility. Use and distribution of any remaining unused product affected by this removal should cease immediately.\nUPN: 6500\nGTIN: 5060271140725\nBatches: 17-C02, 17-C06, 17-C07, 17-C08\n\nUPN: 6700\nGTIN: 5060271140596\nBatches: 17-C01, 17-C03, 17-C04, 17-C05, 17-C09\n\nIf you identify any affected product within your inventory, please segregate the product immediately and return it to Boston Scientific in accordance with the enclosed instructions.\n\nIf you are a distributor, please note that this removal is to the customer level. Please notify any", "product_quantity": "139", "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.", "openfda": { "k_number": [ "K955636", "K891400", "K971187", "K973554", "K881763", "K873654", "K962313", "K050923", "K810628", "K890973", "K905060", "K882421", "K011515", "K161600", "K873655", "K012684", "K873653", "K895331", "K952323", "K780405", "K003403", "K991830", "K974735", "K772160", "K881144", "K890972", "K000333", "K792365", "K903302", "K923037", "K993885", "K950455", "K944992", "K874719", "K962544", "K952290" ], "registration_number": [ "3018094310", "9610617", "3007544634", "3012322232", "1717344", "1219619", "1319660", "3026612481", "3004784537", "3013188547", "1320894", "3010202439", "3010707607", "1220477", "9680721", "3015136673", "1018470", "3043226252", "3013557562", "2020550", "3006546082", "8040510", "3014342096", "3007421149", "3016678045", "3009241989", "2219920", "1058584", "2183744", "3007960282", "9610773", "8010510", "2434839", "1061927", "3002808022", "3004491689", "1319639", "1017294", "1721194", "1721251", "9610614", "3013247477", "3007305485", "1222993", "3012494290", "3011050570", "9681191", "3009762450", "3008361498", "3014891416", "9610849", "3013557681" ], "fei_number": [ "3018094310", "3000226659", "3007544634", "3012322232", "1717344", "1219619", "3013557681", "3026612481", "1000136478", "3004784537", "3013188547", "1000138054", "3010707607", "1220477", "3002808268", "3015136673", "1018470", "3043226252", "3013557562", "2020550", "3006546082", "1000244733", "3014342096", "3002807391", "3007421149", "3016678045", "3009241989", "3002807798", "2219920", "2183744", "3007960282", "2434839", "3000203000", "3002808022", "3001451571", "3001319476", "3004491689", "1721194", "1017294", "1721251", "3013247477", "3007305485", "1000219637", "3007475226", "3012494290", "3011050570", "3002806920", "3009762450", "3008361498", "3014891416", "1000120578", "3008207730" ], "device_name": "Electrode, Electrosurgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ] }