Boston Scientific
Boston Scientific holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2026, with 12 FDA device recalls on record.
Top product codes for Boston Scientific
FDA recalls by Boston Scientific
10 most recent of 12- Z-1734-2020 — Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110
- Z-1731-2020 — Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: M0066703090 single unit
- Z-1739-2020 — Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080
- Z-1733-2020 — Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110
- Z-1736-2020 — Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080
- Z-1735-2020 — Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021)
- Z-1730-2020 — Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M0066703060 single unit
- Z-1737-2020 — Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080
- Z-1738-2020 — Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080
- Z-1740-2020 — Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080
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
- K262460 — Rezum System
- K253692 — AVVIGO+ Multi-Modality Guidance System
- K262406 — EluPro Antibiotic-Eluting BioEnvelope
- K260816 — OptiCross Coronary Imaging Catheter (H749518110) +7 more
- K252910 — Orca Air/Water and Suction Valves
- K251291 — Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers
- K250468 — iSLEEVE Introducer Set
- K242950 — WallFlex Biliary PLUS RX Stent System
- K242507 — OBSIDIO Conformable Embolic
- K240464 — WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
- K233939 — Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
- K234002 — ICEfx Cryoablation System (FPRCH8000-02)
- K232633 — Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter
- K232635 — IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
- K231176 — Stingray LP Catheter
- K230503 — Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable
- K220866 — EKOS+ Endovascular Device
- K220629 — Emerge Monorail PTCA Dilatation Catheter
- K211080 — EkoSonic Endovascular Device
- K210925 — Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber
- K201178 — iLab Polaris Multi-Modality Guidance System
- K190184 — iSLEEVE Introducer Set
- K180068 — ORISE Gel
- K180864 — WATCHMAN TruSeal Access System
- K180102 — Embozene Color-Advanced Microspheres
- K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- K173400 — ORISE Tissue Retractor System
- K173184 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K163058 — Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
- K160751 — Symphion Endoscope and Symphion Cervical Sheath
- DEN150040 — WallFlex Biliary RX Fully Covered Stent System RMV
- K152607 — Express SD Biliary Monorail Premounted Stent System
- K152403 — Permanent Sled Bag
- K152316 — iLab Ultrasound Imaging System
- K143193 — Symmetry and Symmetry Stiff Shaft Balloon Dilatation Catheters
- K141112 — STERLING OVER-THE WIRE PTA BALLOON DILATATION CATHETER
- K140630 — WALLFLEX BILIARY RX STENT SYSTEM
- K140329 — RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT
- K140503 — FLEXIVA SF SIDE-FIRING SINGLE-USE LASER FIBER
- K132914 — ACUITY PRO LEAD DELIVERY SYSTEM
- K140323 — NAVIGATOR HD URETERAL ACCESS SHEATH SETS
- K132253 — REMOVABLE PATIENT LEADS ECG CABLE
- K123765 — GUIDEZILLA GUIDE EXTENSION CATHETER
- K113681 — GLADIATOR PTA BALLOON DILATION CATHETER
- K112697 — CHARGER PTA BALLON DILATATION CATHETER
- K112303 — RUBICON SUPPORT CATHETER
- K112701 — CHARGER BALLOON DILATATION CATHETER
- K110122 — MUSTANG BALLOON DILATAION CATHETERS
- K103751 — MUSTANG BALLOON DILATATION CATHETERS
- K102912 — INTERLOCK FIBERED IDC OCCLUSION SYSTEM
- K091131 — PELVIC FLOOR REPAIR SYSTEM
- K070002 — BOSTON SCIENTIFIC PERIPHERALLY INSERTED CENTRAL CATHETER
- K070951 — 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
- K062387 — SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
- K062050 — FLEXVIEW SYSTEM
- K040787 — MODIFICATION TO SURGICAL MESH POLYMERIC
- K040027 — BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
- K022067 — CONVOY ADVANCED DELIVERY SHEATH
- K020110 — MODIFICATION TO TRELEX MESH SURGICAL MESH
- K020028 — 6F MACH1/34356-XXX; 5F MACH1/35845-XXX; 7F MACH1/34357-XXX; 8F MACH1/34358-XXX
- K013866 — CONVOY ADVANCED DELIVERY SHEATH KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.