{ "companyId": "49487", "slug": "boston-scientific-corporation-49487", "name": "Boston Scientific Corporation", "clearances": { "total": 726, "last12Months": 18, "first": "1988-11-23", "latest": "2026-07-24" }, "medianReviewDays": 77, "productCodeCount": 132, "recalls": { "total": 1246, "openLast12Months": 76, "recent": [ { "resNumber": "Z-2725-2026", "productCode": "KYZ", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-06-30", "reason": "Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure." }, { "resNumber": "Z-2838-2026", "productCode": "FCL", "status": "Open, Classified", "recallClass": null, "initiated": "2026-06-30", "reason": "Potential for breach in sterile barrier of device packaging." }, { "resNumber": "Z-2839-2026", "productCode": "FCL", "status": "Open, Classified", "recallClass": null, "initiated": "2026-06-30", "reason": "Potential for breach in sterile barrier of device packaging." }, { "resNumber": "Z-2840-2026", "productCode": "FCL", "status": "Open, Classified", "recallClass": null, "initiated": "2026-06-30", "reason": "Potential for breach in sterile barrier of device packaging." }, { "resNumber": "Z-2771-2026", "productCode": "LLZ", "status": "Open, Classified", "recallClass": "Class II", "initiated": "2026-06-19", "reason": "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects \"Recalculate\", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation." } ] }, "registration": { "sites": 16, "countries": [ "US" ] }, "productCodes": [ { "code": "FGE", "deviceName": "Stents, Drains And Dilators For The Biliary Ducts", "clearances": 56, "latest": "2025-07-03", "medianReviewDays": 88 }, { "code": "LIT", "deviceName": "Catheter, Angioplasty, Peripheral, Transluminal", "clearances": 52, "latest": "2024-07-10", "medianReviewDays": 87 }, { "code": "DQX", "deviceName": "Wire, Guide, Catheter", "clearances": 34, "latest": "2018-09-26", "medianReviewDays": 49 }, { "code": "DQY", "deviceName": "Catheter, Percutaneous", "clearances": 30, "latest": "2024-02-01", "medianReviewDays": 39 }, { "code": "DQO", "deviceName": "Catheter, Intravascular, Diagnostic", "clearances": 20, "latest": "2015-10-29", "medianReviewDays": 64 }, { "code": "KNS", "deviceName": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)", "clearances": 17, "latest": "2025-06-11", "medianReviewDays": 59 }, { "code": "DYB", "deviceName": "Introducer, Catheter", "clearances": 16, "latest": "2025-03-20", "medianReviewDays": 34 }, { "code": "KRD", "deviceName": "Device, Vascular, For Promoting Embolization", "clearances": 16, "latest": "2026-07-24", "medianReviewDays": 42 }, { "code": "ESW", "deviceName": "Prosthesis, Esophageal", "clearances": 15, "latest": "2026-07-10", "medianReviewDays": 99 }, { "code": "GEI", "deviceName": "Electrosurgical, Cutting & Coagulation & Accessories", "clearances": 15, "latest": "2014-04-17", "medianReviewDays": 29 }, { "code": "DQK", "deviceName": "Computer, Diagnostic, Programmable", "clearances": 14, "latest": "2025-05-28", "medianReviewDays": 82 }, { "code": "DRF", "deviceName": "Catheter, Electrode Recording, Or Probe, Electrode Recording", "clearances": 14, "latest": "2025-06-27", "medianReviewDays": 124 }, { "code": "DSP", "deviceName": "System, Balloon, Intra-Aortic And Control", "clearances": 14, "latest": "1998-02-10", "medianReviewDays": 90 }, { "code": "FAD", "deviceName": "Stent, Ureteral", "clearances": 12, "latest": "2025-04-15", "medianReviewDays": 77 }, { "code": "OBJ", "deviceName": "Catheter, Ultrasound, Intravascular", "clearances": 12, "latest": "2026-04-08", "medianReviewDays": 31 }, { "code": "GEX", "deviceName": "Powered Laser Surgical Instrument", "clearances": 11, "latest": "2026-05-18", "medianReviewDays": 30 }, { "code": "HCG", "deviceName": "Device, Neurovascular Embolization", "clearances": 11, "latest": "2011-02-16", "medianReviewDays": 29 }, { "code": "KRA", "deviceName": "Catheter, Continuous Flush", "clearances": 11, "latest": "2026-05-15", "medianReviewDays": 67 }, { "code": "ITX", "deviceName": "Transducer, Ultrasonic, Diagnostic", "clearances": 10, "latest": "2020-04-17", "medianReviewDays": 78 }, { "code": "KNT", "deviceName": "Tubes, Gastrointestinal (And Accessories)", "clearances": 10, "latest": "2021-04-27", "medianReviewDays": 76 }, { "code": "LOX", "deviceName": "Catheters, Transluminal Coronary Angioplasty, Percutaneous", "clearances": 10, "latest": "2022-03-24", "medianReviewDays": 86 }, { "code": "EZN", "deviceName": "Dilator, Catheter, Ureteral", "clearances": 9, "latest": "2013-05-22", "medianReviewDays": 79 }, { "code": "MQR", "deviceName": "Stent, Colonic, Metallic, Expandable", "clearances": 9, "latest": "2024-03-08", "medianReviewDays": 84 }, { "code": "EOQ", "deviceName": "Bronchoscope (Flexible Or Rigid)", "clearances": 8, "latest": "2023-03-02", "medianReviewDays": 122 }, { "code": "FDI", "deviceName": "Snare, Flexible", "clearances": 8, "latest": "2020-10-08", "medianReviewDays": 52 } ], "productCodesShown": 25, "productCodesTotal": "132", "recentClearances": [ { "kNumber": "K262462", "deviceName": "TheraSphere 360™ Y-90 Management Platform", "productCode": "LLZ", "decisionDate": "2026-07-24", "reviewDays": 7 }, { "kNumber": "K262165", "deviceName": "FARADRIVE™ Steerable Sheath (M004PF21M402)", "productCode": "DRA", "decisionDate": "2026-07-24", "reviewDays": 28 }, { "kNumber": "K261488", "deviceName": "OBSIDIO Conformable Embolic", "productCode": "KRD", "decisionDate": "2026-07-24", "reviewDays": 79 }, { "kNumber": "K261978", "deviceName": "WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System", "productCode": "ESW", "decisionDate": "2026-07-10", "reviewDays": 28 }, { "kNumber": "K260428", "deviceName": "RIVOS™ EUS Access Device (M00553900)", "productCode": "ODG", "decisionDate": "2026-06-17", "reviewDays": 127 }, { "kNumber": "K260100", "deviceName": "MOSES Raydar™", "productCode": "GEX", "decisionDate": "2026-05-18", "reviewDays": 125 }, { "kNumber": "K260771", "deviceName": "TruSelect™ 2.6 Microcatheter", "productCode": "KRA", "decisionDate": "2026-05-15", "reviewDays": 67 }, { "kNumber": "K260816", "deviceName": "OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)", "productCode": "OBJ", "decisionDate": "2026-04-08", "reviewDays": 26 }, { "kNumber": "K251273", "deviceName": "Asurys Fluid Management System", "productCode": "HIG", "decisionDate": "2026-03-27", "reviewDays": 337 }, { "kNumber": "K260479", "deviceName": "TheraSphere 360™ Y-90 Management Platform", "productCode": "LLZ", "decisionDate": "2026-03-13", "reviewDays": 28 } ], "nameVariants": { "total": "15", "shown": [ { "name": "BOSTON SCIENTIFIC CORPORATION", "dataset": "device/registrationlisting", "method": "normalised" }, { "name": "Boston Scientific", "dataset": "device/510k", "method": "normalised" }, { "name": "Boston Scientific", "dataset": "device/recall", "method": "normalised" }, { "name": "Boston Scientific", "dataset": "device/enforcement", "method": "normalised" }, { "name": "Boston Scientific Corp", "dataset": "device/510k", "method": "normalised" }, { "name": "Boston Scientific Corp", "dataset": "device/recall", "method": "normalised" }, { "name": "Boston Scientific Corp", "dataset": "device/enforcement", "method": "normalised" }, { "name": "Boston Scientific Corporation", "dataset": "device/510k", "method": "normalised" } ] }, "sources": { "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Boston%20Scientific%20Corporation%22", "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Boston%20Scientific%20Corporation%22" }, "provenance": [ { "dataset": "device/510k", "loadedAt": "2026-08-10T19:40:09Z", "ingestRun": 51 }, { "dataset": "device/classification", "loadedAt": "2026-08-10T06:54:18Z", "ingestRun": 2 }, { "dataset": "device/enforcement", "loadedAt": "2026-08-10T19:40:12Z", "ingestRun": 53 }, { "dataset": "device/event", "loadedAt": "2026-08-11T13:58:22Z", "ingestRun": 74 }, { "dataset": "device/recall", "loadedAt": "2026-08-10T19:40:11Z", "ingestRun": 52 }, { "dataset": "device/registrationlisting", "loadedAt": "2026-08-10T07:06:24Z", "ingestRun": 10 } ], "retrievedAt": "2026-08-11T14:48:53.020Z" }