Boston Scientific Corporation
FDA Regulatory Profile
Boston Scientific Corporation appears in FDA public data with 620 recalls — including 138 Class I (most serious) —, 233 510(k) clearances, 81 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2725-2026, Class II) was initiated on June 30, 2026. Its most recent 510(k) clearance was granted on July 10, 2026.
Summary
- Total Recalls
- 620 (138 Class I)
- 510(k) Clearances
- 233
- Inspections
- 81
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2725-2026 | Class II | Rapid Refill Continuous Injection System, UPN M00566001 | June 30, 2026 |
| Z-2633-2026 | Class II | CRE Wireguided 8-10mm 240cm | May 21, 2026 |
| Z-2630-2026 | Class II | CRE Pro Wireguided 15-18mm 240cm | May 21, 2026 |
| Z-2635-2026 | Class II | CRE Wireguided 12-15mm 240cm | May 21, 2026 |
| Z-2637-2026 | Class II | CRE Wireguided 18-20mm 240cm | May 21, 2026 |
| Z-2636-2026 | Class II | CRE Wireguided 15-18mm 240cm | May 21, 2026 |
| Z-2629-2026 | Class II | CRE Pro Wireguided 12-15mm 240cm | May 21, 2026 |
| Z-2632-2026 | Class II | CRE Wireguided 6-8mm 240cm | May 21, 2026 |
| Z-2628-2026 | Class II | CRE Pro Wireguided 10-12mm 240cm | May 21, 2026 |
| Z-2626-2026 | Class II | CRE Pro Wireguided 6-8mm 240cm | May 21, 2026 |
| Z-2631-2026 | Class II | CRE Pro Wireguided 18-20mm 240cm | May 21, 2026 |
| Z-2634-2026 | Class II | CRE Wireguided 10-12mm 240cm | May 21, 2026 |
| Z-2627-2026 | Class II | CRE Pro Wireguided 8-10mm 240cm | May 21, 2026 |
| Z-2413-2026 | Class II | Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water V | May 12, 2026 |
| Z-2580-2026 | Class II | Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device | May 11, 2026 |
| Z-2048-2026 | Class II | LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, | March 30, 2026 |
| Z-2049-2026 | Class II | LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe) | March 30, 2026 |
| Z-1771-2026 | Class I | Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model | March 19, 2026 |
| Z-1770-2026 | Class I | Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization | March 19, 2026 |
| Z-1551-2026 | Class II | EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UP | February 10, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | July 10, 2026 |
| K260428 | RIVOS EUS Access Device (M00553900) | June 17, 2026 |
| K260100 | MOSES Raydar | May 18, 2026 |
| K260771 | TruSelect 2.6 Microcatheter | May 15, 2026 |
| K251273 | Asurys Fluid Management System | March 27, 2026 |
| K260479 | TheraSphere 360 Y-90 Management Platform | March 13, 2026 |
| K260119 | SpaceOAR Vue System (SV-2101) | February 10, 2026 |
| K253376 | OBSIDIO Conformable Embolic (M0013972101010) | October 30, 2025 |
| K252529 | Moses 200 D/F/L Laser Fiber (M0068130100); Moses 365 D/F/L Laser Fiber (M0068130110); Moses 550 D | October 30, 2025 |
| K252547 | TheraSphere 360 Y-90 Management Platform | October 28, 2025 |
| K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | September 26, 2025 |
| K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M006794 | September 24, 2025 |
| K252593 | LUX-Dx II Insertable Cardiac Monitor (M302); LUX-Dx II+ Insertable Cardiac Monitor (M312) | September 12, 2025 |
| K251759 | Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva | July 9, 2025 |
| K250310 | VIKING Fixed Curve Diagnostic Catheter | June 27, 2025 |
| K250584 | Rezum System | June 11, 2025 |
| K251344 | OptiMap System | May 28, 2025 |
| K250824 | Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral | April 15, 2025 |
| K250517 | Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access | March 21, 2025 |
| K250066 | Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Cl | February 6, 2025 |