Boston Scientific Corporation recalls Boston Scientific TheraSphere 360 Y-90 Management Platform

Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an input and selects "Recalculate", the dose calculation is updated correctly; however, any vials that were previously added to the cart are not automatically updated to reflect the revised calculation.

Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.

Boston Scientific initially notified their consignees via teleconference on 6/19/2026 and followed with a notice distributed on the same date via email. The notice explained the issue, potential harms, and requested the following: "Required User Actions " Follow the instructions provided in the TheraSphere 360 Ordering Quick Guide. " Remove and reselect vials if inputs into the Activity calculator (Lung Shunt Fraction, Anticipated Residual Waste, and/or Target Volume) are changed after any vials were added to the cart. " Verify that the vial information displayed in the cart and treatment documentation match the final calculation inputs. " Review order information in the attachment to ensure treatment and documentation are as intended. Contact your TheraSphere Consultant to address any impacted treatments or with any questions."

• FDA enforcement recordOfficial FDA database entry for Z-2771-2026
• FDA 510(k) clearance · K252547The device's official FDA premarket clearance record
• FDA 510(k) clearance · K260479The device's official FDA premarket clearance record
• FDA device classification · LLZOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.2050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Boston Scientific CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.