Company · US
Boston Scientific Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2026. Name variants (Inc, Corp, punctuation) are merged.
734510(k) clearances (17 in 12 months)
1,256recalls (49 in 12 months)
852recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 137 |
| DQO | Catheter, Intravascular, Diagnostic | 93 |
| DQY | Catheter, Percutaneous | 89 |
| ESW | Prosthesis, Esophageal | 80 |
| DQX | Wire, Guide, Catheter | 76 |
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | 74 |
| NIP | Stent, Superficial Femoral Artery | 74 |
| KOB | Catheter, Suprapubic (And Accessories) | 62 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 60 |
| GEH | Unit, Cryosurgical, Accessories | 58 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 57 |
| JCT | Prosthesis, Tracheal, Expandable | 56 |
| DQK | Computer, Diagnostic, Programmable | 39 |
| GEX | Powered Laser Surgical Instrument | 34 |
| LWS | Implantable Cardioverter Defibrillator (Non-Crt) | 32 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 31 |
| FCG | Biopsy Needle | 29 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 29 |
| DYB | Introducer, Catheter | 22 |
| FDI | Snare, Flexible | 21 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 11, 2026 | K262151 | SpaceOAR Flex System Boston Scientific Corporation | OVB |
| Sep 3, 2026 | K262460 | Rezum System Boston Scientific | KNS |
| Aug 26, 2026 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System Boston Scientific Corporation | FGB |
| Aug 21, 2026 | K253692 | AVVIGO+ Multi-Modality Guidance System Boston Scientific | DQK |
| Aug 12, 2026 | K262406 | EluPro Antibiotic-Eluting BioEnvelope Boston Scientific | FTM |
| Aug 4, 2026 | K261915 | Navigator Flex Ureteral Access Sheath Set Boston Scientific Corporation | FED |
| Jul 24, 2026 | K262462 | TheraSphere 360 Y-90 Management Platform Boston Scientific Corporation | LLZ |
| Jul 24, 2026 | K262165 | FARADRIVE Steerable Sheath (M004PF21M402) Boston Scientific Corporation | DRA |
| Jul 24, 2026 | K261488 | OBSIDIO Conformable Embolic Boston Scientific Corporation | KRD |
| Jul 10, 2026 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System Boston Scientific Corporation | ESW |
| Jun 17, 2026 | K260428 | RIVOS EUS Access Device (M00553900) Boston Scientific Corporation | ODG |
| May 18, 2026 | K260100 | MOSES Raydar Boston Scientific Corporation | GEX |
| May 15, 2026 | K260771 | TruSelect 2.6 Microcatheter Boston Scientific Corporation | KRA |
| Apr 8, 2026 | K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coro Boston Scientific | OBJ |
| Mar 27, 2026 | K251273 | Asurys Fluid Management System Boston Scientific Corporation | HIG |
| Mar 13, 2026 | K260479 | TheraSphere 360 Y-90 Management Platform Boston Scientific Corporation | LLZ |
| Feb 10, 2026 | K260119 | SpaceOAR Vue System (SV-2101) Boston Scientific Corporation | OVB |
| Oct 30, 2025 | K253376 | OBSIDIO Conformable Embolic (M0013972101010) Boston Scientific Corporation | KRD |
| Oct 30, 2025 | K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D/F/L Laser Fiber (M0 Boston Scientific Corporation | GEX |
| Oct 28, 2025 | K252547 | TheraSphere 360 Y-90 Management Platform Boston Scientific Corporation | LLZ |
| Oct 9, 2025 | K252910 | Orca Air/Water and Suction Valves Boston Scientific | ODC |
| Sep 26, 2025 | K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps Boston Scientific Corporation | BWH |
| Sep 24, 2025 | K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elit Boston Scientific Corporation | FGB |
| Sep 12, 2025 | K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) Boston Scientific Corporation | MXD |
| Jul 9, 2025 | K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Las Boston Scientific Corporation | GEX |
| Jul 3, 2025 | K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers Boston Scientific | FGE |
| Jun 27, 2025 | K250310 | VIKING Fixed Curve Diagnostic Catheter Boston Scientific Corporation | DRF |
| Jun 11, 2025 | K250584 | Rezum System Boston Scientific Corporation | KNS |
| May 28, 2025 | K251344 | OptiMap System Boston Scientific Corporation | DQK |
| Apr 15, 2025 | K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Boston Scientific Corporation | FAD |
| Mar 21, 2025 | K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F Boston Scientific Corporation | FED |
| Mar 20, 2025 | K250468 | iSLEEVE Introducer Set Boston Scientific | DYB |
| Feb 6, 2025 | K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Reso Boston Scientific Corporation | PKL |
| Dec 6, 2024 | K242950 | WallFlex Biliary PLUS RX Stent System Boston Scientific | FGE |
| Nov 15, 2024 | K242960 | AdVance XP Male Sling System (720163-03) Boston Scientific Corporation | OTM |
| Nov 1, 2024 | K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic Boston Scientific Corporation | DRF |
| Oct 18, 2024 | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straigh Boston Scientific Corp | GEH |
| Oct 3, 2024 | K242507 | OBSIDIO Conformable Embolic Boston Scientific | KRD |
| Aug 30, 2024 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV Boston Scientific | FGE |
| Aug 29, 2024 | K241227 | RHYTHMIA HDx Mapping System Boston Scientific Corporation | DQK |
| Jul 10, 2024 | K241683 | Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Cathe Boston Scientific Corporation | LIT |
| Jul 1, 2024 | K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue El Boston Scientific Corporation | FGB |
| Apr 29, 2024 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System Boston Scientific | ESW |
| Apr 4, 2024 | K233837 | Agile Esophageal Stent System Boston Scientific Corporation | ESW |
| Mar 13, 2024 | K234002 | ICEfx Cryoablation System (FPRCH8000-02) Boston Scientific | GEH |
| Mar 8, 2024 | K234046 | WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery Boston Scientific Corporation | MQR |
| Feb 1, 2024 | K240018 | WATCHMAN TruSteer Access System (M635TU90050) Boston Scientific Corporation | DQY |
| Dec 12, 2023 | K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection Boston Scientific Corporation - | FGB |
| Dec 11, 2023 | K233248 | FARADRIVE Steerable Sheath Boston Scientific Corporation | DRA |
| Nov 30, 2023 | K233503 | 14F iSLEEVE Introducer Set Boston Scientific Corporation | DYB |
Newest 50 of 734.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2026 | Boston Scientific Corporation NaviFlex LW Pusher;
Advx Panc. Stent 4/5F;
Material Number (UPN): M00535030; Open, Classified |
FGE | K223592 |
| Sep 23, 2026 | Boston Scientific Corporation Imager II Angiographic Catheters
M001314001
IMAGER II/5/ST/65/038 BX5;
M001314011
IMAGER II/5/ST/100/038 BX5;
M001314021
IMAGER II/5/ST/65/035 BX 5;
M001314031
IMAGER II/5/ST/100/035 BX 5;
M00131 Open, Classified |
DQO | K121694 |
| Sep 16, 2026 | Boston Scientific Corporation Boston Scientific Corporation
StoneSmart Connect Console
Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable
REF: M0067933000, M006793300H0, M006793 Open, Classified |
FGB | K233645 |
| Sep 2, 2026 | Boston Scientific Corporation 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) Open, Classified |
MXD | K231328 |
| Sep 2, 2026 | Boston Scientific Corporation 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) Open, Classified |
MXD | K231328 |
| Sep 2, 2026 | Boston Scientific Corporation 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) Open, Classified |
MXD | K231328 |
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter Open, Classified |
NTE | K230402 |
| Aug 20, 2026 | Boston Scientific Corporation Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter Open, Classified |
NTE | K153485 |
| Aug 14, 2026 | Boston Scientific Corporation Suture Cinch Long 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | K181141 K201808 |
| Aug 14, 2026 | Boston Scientific Corporation OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device. Open, Classified |
OCW | K181141 K201808 |
| Jul 31, 2026 | Boston Scientific Corporation 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. Open, Classified |
FCL | None listed |
| Jul 31, 2026 | Boston Scientific Corporation 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 Open, Classified |
FCL | None listed |
| Jul 31, 2026 | Boston Scientific Corporation Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN:
1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400.
2. Radial Jaw 4 SC 240c Open, Classified |
FCL | None listed |
| Jul 22, 2026 | Boston Scientific Corporation Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. Open, Classified |
LLZ | K252547 K260479 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PFCE21M402, IFU Reference Number 51659727-01 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the chambers of the heart, Material Number M004PF21M402, IFU Reference Number 51654495-01 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21M402, IFU Reference Number LBL1062 Open, Classified |
DRA | K233248 |
| Jul 20, 2026 | Boston Scientific Corporation FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, Material Number 21C602, IFU Reference Number 51636751-01 Open, Classified |
DRA | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 17, 2026 | Boston Scientific Corporation FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Catheter Open, Classified |
QZI | None listed |
| Jul 10, 2026 | Boston Scientific Corporation Rapid Refill Continuous Injection System, UPN M00566001 Open, Classified |
KYZ | None listed |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 18-20mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 15-18mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 12-15mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 10-12mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 8-10mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Wireguided 6-8mm 240cm Open, Classified |
FDT | K110833 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 18-20mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 15-18mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 12-15mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 10-12mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 8-10mm 240cm Open, Classified |
FGE | K112994 |
| Jul 1, 2026 | Boston Scientific Corporation CRE Pro Wireguided 6-8mm 240cm Open, Classified |
FGE | K112994 |
| Jun 25, 2026 | Boston Scientific Corporation Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device Completed |
LKK | None listed |
| Jun 11, 2026 | Boston Scientific Corporation Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastroint Open, Classified |
ODC | K252910 |
| May 1, 2026 | Boston Scientific Corporation LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Vers Open, Classified |
MXD | K231328 |
| May 1, 2026 | Boston Scientific Corporation LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5 Open, Classified |
MXD | K231328 |
| Apr 24, 2026 | Boston Scientific Corporation Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as:
1. VALITUDE CRT-P EL, Model Number U125;
2. VALITUDE CRT-P EL MRI, Model Number U128;
3. VISIONIST CRT-P EL, Model Number U225; Open, Classified |
NKE | None listed |
| Apr 24, 2026 | Boston Scientific Corporation Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as:
1. ESSENTIO SR SL, Model Number L100;
2. ESSENTIO DR SL Pacemaker, Model Nu Open, Classified |
LWP | None listed |
| Mar 11, 2026 | Boston Scientific Corporation EndoVive Safety PEG Kit;
Outer Box Material Number (UPN): M00509001;
Inner Box Material Number (UPN): M00509000; Open, Classified |
PIF | K150679 |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm;
Material Number (UPN): M00553560; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm;
Material Number (UPN): M00553530; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm;
Material Number (UPN): M00553520; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;
Material Number (UPN): M00553690; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm;
Material Number (UPN): M00553680; Open, Classified |
KNS | K233318 |
| Feb 5, 2026 | Boston Scientific Corporation AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm;
Material Number (UPN): M00553660; Open, Classified |
KNS | K233318 |
| Jan 9, 2026 | Boston Scientific Corporation Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F,
1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210;
2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;
Cat Open, Classified |
LIT | K111295 |
| Oct 10, 2025 | Boston Scientific Corporation LGX Preconnect with TENACIO Pump with InhibiZone;
UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) Open, Classified |
JCW | None listed |
Newest 50 of 1,256.