Boston Scientific TheraSphere 360 Y-90 Management Platform: recall status

Notice names this product. Boston Scientific’s Boston Scientific TheraSphere 360 Y-90 Management Platform is named in FDA Class II recall Z-2771-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: 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. Identifying details: UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2). Units affected: 68 units. Status: Ongoing.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Boston Scientific TheraSphere 360 Y-90 Management Platform
Company / brand: Boston Scientific
Lot / serial / date codes: UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
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.

Agency product description and boundaries

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

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

Brand: Boston Scientific

Recalls naming this model

FDA Class II · Medical device · July 29, 2026

Boston Scientific TheraSphere 360 Y-90 Management Platform recall — Boston Scientific Corporation

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 inpu…

Company / brand: Boston Scientific

Affected product: Boston Scientific TheraSphere 360 Y-90 Management Platform

Official ID Z-2771-2026 · Official record ↗

See all Boston Scientific recalls →

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.