{ "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": "177422", "product_res_number": "Z-0577-2020", "event_date_initiated": "2019-10-24", "event_date_created": "2019-11-26", "recall_status": "Terminated", "event_date_terminated": "2023-03-20", "res_event_number": "84152", "product_code": "LOX", "k_numbers": [ "K113220", "K121196", "K130391", "K163174" ], "product_description": "Emerge Monorail PTCA Dilatation Catheter. Sterilized using ethylene oxide. Packaged in the following sizes: 1. REF/Catalog No. H7493919308200 EMERGE MR, OUS 2.00mm X 8mm; \n2. REF/Catalog No. H7493918912200, EMERGE MR US 2.00MM X 12MM; \n3. REF/Catalog No. H7493919312200, EMERGE MR, OUS 2.00mm X 12mm; \n4. REF/Catalog No. H7493918912250, EMERGE MR US 2.50MM X 12MM; \n5. REF/Catalog No. H7493919312250, EMERGE MR, OUS 2.50mm X 12mm; \n6. REF/Catalog No. H7493918912300, EMERGE MR US 3.00MM X 12MM; \n7. REF/Catalog No. H7493919312300, EMERGE MR, OUS 3.00mm X 12mm; \n8. REF/Catalog No. H7493918915150, EMERGE MR US 1.50MM X 15MM; \n9. REF/Catalog No. H7493919315150, EMERGE MR, OUS 1.50mm X 15mm; \n10. REF/Catalog No. H7493918915200, EMERGE MR US 2.00MM X 15MM, \n11. REF/Catalog No. H7493919315200, EMERGE MR, OUS 2.00mm X 15mm; \n12. REF/Catalog No. H7493919315250, EMERGE MR, OUS 2.50mm X 15mm; \n13. REF/Catalog No. H7493918915300, EMERGE MR US 3.00MM X 15MM; \n14. REF/Catalog No. H7493919315300, EMERGE MR, OUS 3.00mm X 15mm; \n15. REF/Catalog No. H7493918915350, EMERGE MR US 3.50MM X 15MM; \n16. REF/Catalog No. H7493919315350, EMERGE MR, OUS 3.50mm X 15mm; \n17. REF/Catalog No. H7493919320200, EMERGE MR, OUS 2.00mm X 20mm; \n18. REF/Catalog No. H7493919320250, EMERGE MR, OUS 2.50mm X 20mm; \n19. REF/Catalog No. H7493919320300, EMERGE MR, OUS 3.00mm X 20mm; \n20. REF/Catalog No. H7493919415120, EMERGE PUSH MR, OUS 1.20mm X 15mm.", "code_info": "Lot / GTIN Number / Use By: 1. 24112923 / 8714729799788 / 2022-03-12 2.\t Lot: 21362152 / 8714729806080 / 2020-07-06, 3.\tLots: 21311605 / 8714729799894 / 2020-06-23, 23960557 / 8714729799894 / 2022-02-11, 23975925 / 8714729799894 / 2022-02-13, 24112926 / 8714729799894 / 2022-03-12.  4.\tLots: 20524227 / 8714729806103 / 2019-12-31, 22402212 / 8714729806103 / 2021-03-15, 22909685 / 8714729806103 / 2020-12-06.  5.\tLots: 23881230 / 8714729799917 / 2022-01-25, 23881291 / 8714729799917 / 2022-01-25, 24088571 / 8714729799917 / 2022-03-07, 24143068 / 8714729799917 / 2022-03-18.  6.\tLots: 22374160 / 8714729806127 / 2021-03-09, 22532219 / 8714729806127 / 2021-04-16, 22760617 / 8714729806127 / 2021-02-05, 23021557 / 8714729806127 / 2021-01-11, 23181062 / 8714729806127 / 2021-09-10, 23578933 / 8714729806127 / 2021-04-16.  7.\tLot: 22799195 / 8714729799931 / 2021-06-12.  8.\tLots: 20361236 / 8714729806189 / 2019-10-31, 22619082 / 8714729806189 / 2021-05-03.  9.\tLot: 24088574 / 8714729799993 / 2022-03-07.  10.\tLots: 20985435 / 8714729806196 / 2020-04-04, 22416559 / 8714729806196 / 2021-03-19.  11.\tLots: 21308852 / 8714729800002 / 2020-06-23, 21309387 / 8714729800002 / 2020-06-23, 21363021 / 8714729800002 / 2020-07-06, 23989173 / 8714729800002 / 2022-02-15.  12.\tLots: 20909603 / 8714729800026 / 2020-03-15, 22734757 / 8714729800026 / 2021-05-29, 23047327 / 8714729800026 / 2021-08-03, 23946181 / 8714729800026 / 222-02-07, 24151134 / 8714729800026 / 2022-03-19.  13.\tLot: 23924000 / 8714729806233 / 2022-02-04.  14.\tLots: 23272475 /8714729800040 / 2021-09-27 , 23541254 / 8714729800040 / 2021-11-20.  15.\tLot: 23901505 / 8714729806257 / 2022-01-30.  16.\tLot: 24133473 / 8714729800064 / 2022-03-15.  17.\tLots: 23272477 / 8714729800118 / 2021-09-21, 23324727 / 8714729800118 / 2021-10-08.  18.\tLots: 20452512 / 8714729800132 / 2019-11-30, 20669615 / 8714729800132 / 2020-01-15, 23408005 / 8714729800132 / 2021-10-24.  19.\tLots: 21500615 / 8714729800156 / 2020-08-08, 23518523 / 8714729800156 / 2021-11-15.  20.\tLot: 23364688 / 8714729799702 / 2021-10-16.", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "reason_for_recall": "Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.", "root_cause_description": "Process control", "action": "The firm, Boston Scientific, sent an \"Urgent Medical Device Removal\" letter dated 10/28/2019 overnight mail delivery to its customers. The letter stated the issue, identified affected product and stated that product should not be used. The customers were instructed, if any product is identified to segregate immediately and return to Boston Scientific. The customers were also instructed to Immediately complete the RECALL REMOVAL REPLY VERIFICATION TRACKING FORM and Scan/e-mail to: BSCFieldActionCenter@bsci.com OR Fax to #: 1-866-213-1806. This form must be completed and returned in all cases even if you do not have any affected product.\n\nIf you are a distributor, please note that the removal notification should be forwarded to your customers.\n\nIf you have any questions, contact Boston Scientific Quality Systems at\n763-494-1133 or email: BSCFieldActionCenter@bsci.com.", "product_quantity": "14,145 devices total", "distribution_pattern": "Nationwide including Washington D.C. and Puerto Rico.\nOUS to include Canada.", "openfda": { "k_number": [ "K896108", "K123264", "K252116", "K110133", "K153742", "K150292", "K212393", "K133633", "K820410", "K251970", "K861847", "K162209", "K123279", "K163174", "K220634", "K180040", "K242969", "K121196", "K180921", "K110617", "K261428", "K103095", "K153682", "K163114", "K141236", "K261759", "K121222", "K203390", "K121667", "K152485", "K220629", "K122178", "K211807", "K211393", "K141025", "K230374", "K141090", "K160823", "K160961", "K143480", "K141933", "K143160", "K130391", "K131450", "K113775", "K182699", "K233729", "K162625", "K181023", "K223189", "K160985", "K211349", "K134031", "K210012", "K111544", "K131169", "K223022", "K173581", "K843944", "K163200", "K103808", "K103153", "K112735", "K103110", "K163372", "K172264", "K133852", "K111284", "K202619", "K163660", "K123473", "K200269", "K170941", "K254022", "K162434", "K222538", "K192344", "K113464", "K230705", "K233499", "K121681", "K173680", "K233505", "K113220", "K202578", "K252295", "K103657", "K110134" ], "pma_number": [ "P990008", "P860019", "P880003", "P930012", "P870021", "P970052", "P790017", "P880027", "P950020", "P850021", "P890048", "P960014", "P910031", "P890032", "P940009", "P840040", "P880065", "P870036", "P810046", "P020037", "P880055", "P890001" ], "registration_number": [ "", "3010432890", "3011564431", "3015453963", "3009018440", "3002807315", "3004824117", "2124215", "3013152301", "3009965866", "8010026", "3006946276", "3014222368", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "8043892", "3018805824", "2011171", "2134812", "1000121056", "1225687", "1721686", "3013546453", "3008824097", "3007156625", "3003898360", "3012693555", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "2134265", "3004415014", "3003775186", "3008573567", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "1422634", "9617601", "3007836437", "2024168", "3010131137", "9681834", "3009205152", "3012167431", "9612164", "3044156918", "3024893679", "9614654", "3014390222", "3019807891", "3003084171", "3009564766", "3015910259", "3010220595", "3043534762", "2183744", "1319639", "1028232", "2939561", "3010273872", "9681260", "3006513822", "3013944123", "3011137372", "3009613036", "3017262662", "3035111606", "3010391265", "9710284", "3034695832" ], "fei_number": [ "", "3010432890", "3011564431", "3015453963", "1000138054", "3005747797", "3009018440", "3002807315", "3004824117", "3002808050", "3001451463", "2124215", "3013152301", "2828", "3009965866", "3002827704", "1000514656", "3006946276", "3002808904", "3002808327", "3014222368", "3002806434", "3016678045", "3006550224", "3008700817", "3013341368", "3002807314", "3018805824", "2011171", "1000121056", "1721686", "3013546453", "3008824097", "3003898360", "3012693555", "3002806565", "3014461810", "3004091615", "3012050423", "3015002281", "3030421123", "3031550970", "3004635528", "3004415014", "3003775186", "3008573567", "3008133910", "3030236028", "3013634084", "3014656749", "3008002401", "3017961114", "1313046", "3002095335", "3002534070", "3007836437", "2024168", "3010131137", "3009205152", "3012167431", "3044156918", "3024893679", "3014390222", "3019807891", "3003084171", "3009564766", "3003182398", "3015910259", "3010220595", "3043534762", "2183744", "1028232", "3010273872", "3006513822", "3013944123", "3009613036", "3017262662", "3035111606", "3010391265", "3034695832" ], "device_name": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5100", "device_class": "2" } } ] }