Lower risk Medical device recall · FDA · Published June 19, 2026

Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall

Boston Scientific recalls TheraSphere 360 Y-90 Management Platform software versions with a calculation error when modifying inputs after adding vials to cart. Affected units may need correction.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2771-2026Medical device Boston Scientific ›

Lower-risk 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.

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling a specific software version of their TheraSphere 360 Y-90 Management Platform due to an error in dose calculations when users modify inputs after adding vials to the cart. This could lead to incorrect radiation dosing during medical procedures. Read more at govinfonow.com/recall/127767-boston-scientific-therasphere-360-y-90-software-anomaly-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/127767-boston-scientific-therasphere-360-y-90-software-anomaly-recall · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2771-2026

Cite this page

“Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127767-boston-scientific-therasphere-360-y-90-software-anomaly-recall. Based on FDA recall #Z-2771-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2771-2026%22&limit=1).

The FDA announced on June 19, 2026, that Boston Scientific Corporation is recalling its TheraSphere 360 Y-90 Management Platform due to a software anomaly. The hazard involves incorrect dose calculation updates when users modify inputs after adding vials to the cart.

How to tell if you have it

Brand: Boston Scientific
Product: TheraSphere 360 Y-90 Management Platform
Model Number: M00139509001
UDI/DI: 00191506068264
Versions: V1.1.2, V1.2.1, V1.2.2, V2.0.1, V2.0.2
Quantity: 68 units

The hazard

According to the FDA, a software anomaly occurs when a user adds vials to the cart and then returns to the Activity Calculator to modify an input. When the user selects "Recalculate," the dose calculation updates correctly, but previously added vials are not automatically updated to reflect the revised calculation.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the August 24, 2026, Imager II Angiographic Catheters Recall for tip fracture risk and the August 6, 2026, LUX-Dx Cardiac Monitor System Recall for delayed AF burden alerts. Other recent recalls of similar products include RayStation/RayPlan Software Recall (November 28, 2025), RayStation 2024B Software Recall (November 28, 2025), and RayStation 10B Software May Cause Radiation Dose Errors - Recall (November 28, 2025).

How to tell if you have this one

Check if you have the TheraSphere 360 Y-90 Management Platform with model number M00139509001 and software versions V1.1.2, V1.2.1, V1.2.2, V2.0.1, or V2.0.2. The product was sold with UDI/DI 00191506068264.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your software version by checking the product's documentation or settings menu.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 26 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 40 days after the firm started it.

Jun 19, 2026Firm started the recall
Jul 22, 2026FDA classified it Class II
Jul 29, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this recall dangerous?

The recall addresses a software error that could lead to incorrect radiation dosing, but it does not pose an immediate risk of serious injury.

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Link to this recall

<a href="https://govinfonow.com/recall/127767-boston-scientific-therasphere-360-y-90-software-anomaly-recall">Boston Scientific TheraSphere 360 Y-90 Software Anomaly Recall (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2771-2026 (June 19, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2771-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.