Boston Scientific TheraSphere 360 Y-90 Management Platform… recallZ-2771-2026 · Boston Scientific Corporation · initiated Jun 19, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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."
Recall details
- Recall number
- Z-2771-2026
- Status
- Open, Classified
- Initiated by the company
- Jun 19, 2026
- Posted by the FDA
- Jul 22, 2026
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 68 units
- Product code
- LLZ
- FDA submissions
- K252547, K260479
- Distribution
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, LA, MA, MN, NE, NY, OH, OK, OR, SC, SD, TN, TX, UT, WA, WI, WV, WY.
Product description
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Code information (models, lots, serial numbers)
UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TheraSphere 360™ M00139509001Boston Scientific Corporation · System, image processing, radiological1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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