Boston Scientific
FDA Regulatory Profile
Summary
- Total Recalls
- 19 (1 Class I)
- 510(k) Clearances
- 490
- Inspections
- 15
- Compliance Actions
- 0
Known Names
cameron health, boston-scientific, baylis medical, preventice solutions, boston-scientific-corporation, guidant corporation, guidant sales corporation, american medical systems, american medical systems holdings, boston-scientific-neuromodulation-corporation
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1732-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .0383CM FLEX ANG/150CM UPN: M0066703101 box 5 UPN: M | March 9, 2020 |
| Z-1736-2020 | Class II | Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 | March 9, 2020 |
| Z-1729-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX STR/150CM UPN: M0066703051 box 5 UPN: M006 | March 9, 2020 |
| Z-1730-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .035 3CM FLEX /150CM UPN: M0066703061 box 5 UPN: M00667 | March 9, 2020 |
| Z-1734-2020 | Class II | Percuflex Plus Ureteral Stent Set 6FX26CM with .038 Sensor UPN: M006175263110 | March 9, 2020 |
| Z-1739-2020 | Class II | Stretch VL Ureteral Stent Set 7FX22-30CM with .035 Sensor UPN: M006185157080 | March 9, 2020 |
| Z-1733-2020 | Class II | Percuflex Plus Ureteral Stent Set 6FX24CM with .038 Sensor UPN: M006175262110 | March 9, 2020 |
| Z-1735-2020 | Class II | Percuflex Plus Ureteral Stent Set 7FX24CM with .035 Sensor UPN: M006175272080 (edited 1/13/2021) | March 9, 2020 |
| Z-1737-2020 | Class II | Stretch VL Ureteral Stent Set 4.8FX22-30CM with .035 Sensor UPN: M006185155080 | March 9, 2020 |
| Z-1731-2020 | Class II | Sensor Nitinol Wire with Hydrophilic Tip .038 3CM FLEX STR/150CM UPN: M006670309 1box 5 UPN: | March 9, 2020 |
| Z-1738-2020 | Class II | Stretch VL Ureteral Stent Set 6FX22- 30CM with .035 Sensor UPN: M006185156080 | March 9, 2020 |
| Z-1740-2020 | Class II | Polaris Ultra Ureteral Stent Set 6FX24CM with .035 Sensor UPN: M006192132080 | March 9, 2020 |
| Z-0465-2016 | Class II | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 ; Material Number: M004PM4790N40; Catalog | November 20, 2015 |
| Z-0462-2016 | Class II | IntellaTip MiFi XP Asymmetric (N4) Curve, 7/110/2.5/8-8 OUS; Material Number: M004EPM4500N40; Cata | November 20, 2015 |
| Z-0463-2016 | Class II | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-10 OUS; Material Number: M004EPM4790N40; Cata | November 20, 2015 |
| Z-0464-2016 | Class II | IntellaTip MiFi XP Asymmetric (N4) Curve 7/110/2.5/8-8 Material Number: M004PM4500N40; Catalog num | November 20, 2015 |
| Z-0402-2016 | Class II | One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube. | September 11, 2015 |
| Z-1209-2015 | Class I | IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Ca | February 3, 2015 |
| Z-0580-2015 | Class II | IntellaMap Orion High Resolution Mapping Catheter; Material number: M004RC64S0; Catalog number RC64 | November 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252910 | Orca Air/Water and Suction Valves | October 9, 2025 |
| K251291 | Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers | July 3, 2025 |
| K250468 | iSLEEVE Introducer Set | March 20, 2025 |
| K242950 | WallFlex Biliary PLUS RX Stent System | December 6, 2024 |
| K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); I | October 18, 2024 |
| K242507 | OBSIDIO Conformable Embolic | October 3, 2024 |
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent | August 30, 2024 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | April 29, 2024 |
| K234002 | ICEfx Cryoablation System (FPRCH8000-02) | March 13, 2024 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Cathet | November 28, 2023 |
| K232635 | IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) | November 22, 2023 |
| K231328 | LUX-Dx II (M302); LUX-Dx II+ (M312) | August 19, 2023 |
| K231176 | Stingray LP Catheter | May 25, 2023 |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable | April 25, 2023 |
| K220866 | EKOS+ Endovascular Device | April 20, 2022 |
| K220629 | Emerge Monorail PTCA Dilatation Catheter | March 24, 2022 |
| K211080 | EkoSonic Endovascular Device | November 19, 2021 |
| K210925 | Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva | April 28, 2021 |
| K201178 | iLab Polaris Multi-Modality Guidance System | May 29, 2020 |
| K190184 | iSLEEVE Introducer Set | March 7, 2019 |