Recall Z-2771-2026

Reason for recall

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.

FDA-determined cause: Device Design

Action taken

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."