Boston Scientific Corporation
Boston Scientific Corporation holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 639 FDA device recalls on record.
Name variants for Boston Scientific Corporation
as filed with FDA- Boston Scientific Corporation
- Boston Scientific Corporation -
Top product codes for Boston Scientific Corporation
FDA recalls by Boston Scientific Corporation
10 most recent of 639- Z-3081-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Versions (Current 7.8)
- Z-3083-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ, Model Number 7248, All Versions (Current 7.7)
- Z-3082-2026 — LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU, Model Number 7246, All Versions (Current 7.7)
- Z-2961-2026 — OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
- Z-2962-2026 — Suture Cinch Long 1pk. Endoscopic tissue approximation device.
- Z-2978-2026 — Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
- Z-2977-2026 — Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
- Z-2725-2026 — Rapid Refill Continuous Injection System, UPN M00566001
- Z-2840-2026 — Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
- Z-2839-2026 — Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial Jaw 4 LC w/Needle 240cm Box 20; Outer Box UPN: M00513331; Inner Box UPN: M00513330. 4. Radial Jaw 4 LC w/Needle 240cm Box 40; Outer Box UPN: M00513332; Inner Box UPN: M00513330. 5. Radial Jaw 4 LC w/Needle 240cm Box 5; Outer Box UPN: M00513333; Inner Box UPN: M00513330.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Boston Scientific Corporation
1–100 of 239- K262151 — SpaceOAR Flex System
- K261153 — LithoVue Elite Digital Flexible Ureteroscope System
- K261915 — Navigator Flex Ureteral Access Sheath Set
- K261488 — OBSIDIO Conformable Embolic
- K262165 — FARADRIVE Steerable Sheath (M004PF21M402)
- K262462 — TheraSphere 360 Y-90 Management Platform
- K261978 — WallFlex Esophageal Stent System; Agile Esophageal Over-the-Wire (OTW) Stent System
- K260428 — RIVOS EUS Access Device (M00553900)
- K260100 — MOSES Raydar
- K260771 — TruSelect 2.6 Microcatheter
- K251273 — Asurys Fluid Management System
- K260479 — TheraSphere 360 Y-90 Management Platform
- K260119 — SpaceOAR Vue System (SV-2101)
- K252529 — Moses 200 D/F/L Laser Fiber (M0068130100) +2 more
- K253376 — OBSIDIO Conformable Embolic (M0013972101010)
- K252547 — TheraSphere 360 Y-90 Management Platform
- K252921 — Radial Jaw 4 Pulmonary Biopsy Forceps
- K252703 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000) +1 more
- K252593 — LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312)
- K251759 — Flexiva Pulse Laser Fiber +3 more
- K250310 — VIKING Fixed Curve Diagnostic Catheter
- K250584 — Rezum System
- K251344 — OptiMap System
- K250824 — Percuflex Ureteral Stent +11 more
- K250517 — Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210) +6 more
- K250066 — Resolution Clip (6 models)
- K242960 — AdVance XP Male Sling System (720163-03)
- K240366 — EPXT Unidirectional Steerable Diagnostic Catheter +2 more
- K241227 — RHYTHMIA HDx Mapping System
- K241683 — Sterling MONORAIL PTA Balloon Dilatation Catheter (6+ models)
- K241598 — LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000) +3 more
- K233837 — Agile Esophageal Stent System
- K234046 — WallFlex Colonic Stent System with Anchor Lock Delivery System +3 more
- K240018 — WATCHMAN TruSteer Access System (M635TU90050)
- K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection
- K233248 — FARADRIVE Steerable Sheath
- K233503 — 14F iSLEEVE Introducer Set
- K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K233318 — AXIOS Stent and Electrocautery-Enhanced Delivery System (6 models)
- K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- K230884 — AVVIGO'+ Multi-Modality Guidance System
- DEN230019 — AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) +1 more
- K232162 — Autotome Pro RX 39 Sphincterotome +6 more
- K223633 — Rubicon Control Support Catheter (H749394323506A1)
- K230551 — Visual-ICE Cryoablation System
- K230269 — Ultraflex Tracheobronchial Stent System
- K231549 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K230706 — EMBOLD Soft Detachable Coil System
- K231533 — Habib EndoHPB
- K223469 — WallFlex Biliary RX Stent System
- K230453 — OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
- K223824 — POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor
- K221340 — iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210)
- K230051 — 14F iSLEEVE Introducer Set
- K221515 — StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring
- K223616 — Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
- K223592 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K211934 — APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
- K222568 — OptiCross 18 Peripheral Imaging Catheter
- K222503 — Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip
- K220112 — AXIOS Stent and Electrocautery-Enhanced Delivery System
- K220962 — ROTAPRO Rotational Atherectomy System
- K221124 — MANTIS Clip
- K222014 — EXALT Model B Single-Use Bronchoscope
- K220796 — IntellaMap Orion High Resolution Mapping Catheter
- K212582 — SpyGlass Discover Balloon Dilation Catheter
- K213398 — EMBOLD Fibered Detachable Coil System
- K203548 — EndoArmor + Surgical Gown
- K213593 — OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
- K211847 — AdVance XP Male Sling System
- K213422 — EkoSonic Endovascular Device, EKOS+ Endovascular Device
- K211960 — Agile Esophageal OTW Stent System
- K212490 — AVVIGO Guidance System II
- K211494 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K211375 — Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter
- K212228 — WATCHMAN FXD Curve Access System
- K211030 — EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
- K211223 — Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
- K210889 — iLab Polaris Multi-Modality Guidance System
- K203322 — SpyGlass Discover Retrieval Basket
- K210608 — LUX-Dx Insertable Cardiac Monitor
- K210353 — AutoCap RX
- K211072 — Safety Trocar Cannula
- K200260 — Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
- K203132 — AXIOS Stent and Electrocautery Enhanced Delivery System
- K203162 — Advanix Biliary Stent with NaviFlex RX Delivery System
- K200404 — ORISE ProKnife
- K202478 — Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares
- K202584 — iSleeve Introducer Set
- K202218 — ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
- K201170 — Athletis PTA Balloon Dilatation Catheter
- K193424 — Resolution 360 ULTRA Clip
- K202224 — SpaceOAR System
- K201159 — WallFlex Colonic Stent System with Anchor Lock Delivery System
- K201792 — TRUSELECT Microcatheter
- K201713 — AVVIGO Guidance System
- K193473 — LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US
- K200483 — SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller
- K200257 — WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
- K200733 — Opticross 35 15 MHz Peripheral Imaging Catheter
Data sourced from openFDA. This site is unofficial and independent of the FDA.