{ "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": "42034", "product_res_number": "Z-0041-06", "event_date_initiated": "2005-09-23", "event_date_posted": "2005-10-28", "recall_status": "Terminated", "event_date_terminated": "2006-10-24", "res_event_number": "33529", "product_code": "FBK", "product_description": "Enteryx Injector Single Pack \nOrder Number: M00572650-US and M00572630 -OUS", "code_info": "All lots codes", "firm_fei_number": "3001451463", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Boston Scientific Pl", "city": "Natick", "state": "MA", "postal_code": "01760-1536", "additional_info_contact": "Cindy Finney\n508-683-4678", "reason_for_recall": "Incorrect implantation may cause serious health complications", "root_cause_description": "Other", "action": "Boston Scientific issued Recall notification by FED'X on 9/23/05 as follows\n Customers/ Hospital Account / Distributors: A Recall Notification Package will be sent to the risk manager of each hospital account via FedEx. This package contains a Recall Notification Letter, instructions on how to return product, a Recall Verification Form, and a Physician Letter that provides recommendations of patient follow-up. .\n\nPhysicians Trained in the Enteryx Procedure: All physicians that attended the physician training program sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided to assist in their communication to the patient.\n\nPatient Letter / Patient Phone Script: A letter and phone script, from the physician to the patient, will be provided to the physician to assist in the physician's communication to patient. The letter informs the patient of the recall and asks them to contact their physician and the Patient Phone Script provides a template to initiate a discussion with the patient. \n\nPhysicians Participating in Post Approval Studies: All physicians that are participating in post approval studies will be sent, via FedEx, a Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone script will be provided to assist in their communication to the patient.\n\nInternal Review Boards (IRBs): All IRBs that are participating in post approval studies will be sent, via FedEx, a IRB Letter and the Physician Letter notifying them of the voluntary recall and providing them with firm's recommendations on patient follow-up. In addition a copy of the Patient Letter and Patient Phone Script will be provided. \n\nBoston Scientific has posted the recall to their website:http://www", "product_quantity": "M00572650=4080 Single; M00572630 =217 Single", "distribution_pattern": "Nationwide\n:", "openfda": { "k_number": [ "K961846", "K954519", "K111495", "K950976", "K990996", "K190032", "K924102", "K001146", "K232200", "K960519", "K061222", "K955558", "K151475", "K220292", "K082319", "K812057", "K002323", "K113634", "K192498", "K190829", "K983765", "K212668", "K820973", "K172227", "K051905", "K241595", "K914496", "K022484", "K010448", "K241523", "K152035", "K902736", "K043383", "K180214", "K953441", "K042882", "K941305", "K011484", "K181690", "K121337", "K982890", "K903668", "K213239", "K901437", "K213914", "K865086", "K855176", "K090830", "K092090", "K232826", "K896424", "K012977", "K894868", "K210917", "K013712", "K240675", "K153625", "K133148", "K030451", "K171454", "K921800", "K221085", "K933815", "K253598", "K000646", "K252021", "K872060", "K221054", "K142144", "K091391", "K002573", "K031238", "K132065", "K222006", "K851952", "K171602", "K951648", "K002778", "K834403", "K090217", "K150434", "K260262", "K953338", "K230925", "K050688", "K883093", "K232442", "K252247", "K042615" ], "registration_number": [ "3004837686", "3008048800", "1828424", "3027269340", "3017390965", "3017178358", "3011146996", "3035451914", "9681260", "3006750742", "3005099803", "3015142721", "1722746", "3025311469", "3030447506", "3007695959", "9680809", "3012649202", "3017448360", "3043141270", "3003814961", "3008693678", "9610614", "3002647932", "1721676", "3011270181", "1000393132", "3010515547", "3000279801", "3004207966", "1220592", "3014769442", "3021632375", "3014342096", "3012480535", "3035434483", "3014620201", "3006621103", "1037905", "3015042209", "8010047", "3008797804", "1825146", "9680001", "2134494", "1222168", "1000121056", "3010273872", "1056129", "1643817", "3004129994", "3010288205", "1528319", "3005580113", "2020550", "3010202439", "3004784537", "3010419931", "1647149", "2246552", "3008274780", "3013440400", "1047843", "3011193403", "3021023752", "1519132", "2183446", "3009888344", "3011050570", "3012042439", "3015895045", "3009747810", "3011707784", "3005987240", "9610711", "3010188783", "3027454635", "3007699067", "3005941719", "1061927", "3018116884", "3013460719", "3008040402", "1018233", "3003790304", "3007156625", "3010707607", "9614641", "9610617", "3013526170", "3004083736", "3017262662", "3013023255", "3015972753", "2431166", "3008573567", "3009064553", "1820334" ], "fei_number": [ "3004837686", "3008048800", "1828424", "3027269340", "3017390965", "3017178358", "3011146996", "3035451914", "3006750742", "3005099803", "3015142721", "3025311469", "3030447506", "3007695959", "3012649202", "3002806565", "3017448360", "3043141270", "3003814961", "3008693678", "3008133910", "3002808268", "3002647932", "1000122656", "1721676", "2523865", "3011270181", "3002619738", "1000393132", "3002808445", "3010515547", "3000279801", "3004207966", "3000203000", "1220592", "3014769442", "3021632375", "3014342096", "3012480535", "3035434483", "3014620201", "3006621103", "1037905", "3015042209", "3008797804", "1825146", "1000306139", "3002807917", "1000306216", "1222168", "1000121056", "3007475226", "3010273872", "3003995201", "1643817", "3004129994", "3010288205", "3005580113", "2020550", "3004784537", "3010419931", "2246552", "3008274780", "3013440400", "1047843", "3011193403", "3021023752", "1519132", "2183446", "3009888344", "3011050570", "3012042439", "3015895045", "3009747810", "3011707784", "3002806920", "3005987240", "3002995060", "3010188783", "3027454635", "3007699067", "3018116884", "3013460719", "3008040402", "3002807795", "1018233", "3003790304", "3010707607", "3002807111", "3013526170", "3004083736", "3017262662", "1000132436", "3013023255", "3015972753", "3008573567", "3009064553", "1820334" ], "device_name": "Endoscopic Injection Needle, Gastroenterology-Urology", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }