Boston Scientific TheraSphere 360 Y-90 Management Platform Recall
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Boston Scientific Corporation is recalling 68 units of its TheraSphere 360 Y-90 Management Platform due to a software anomaly affecting dose calculations.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 12, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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What Happened A 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 inputs. 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.
Which Products Are Affected Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System. UDI/DI 00191506068264. All released software versions (V1.1.2, V1.2.1, V1.2.2, V2.0.1, V2.0.2). 68 units distributed nationwide including in 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. Recall number Z-2771-2026. Recall initiated June 19, 2026.
What You Should Do Users should verify calculations manually after any modifications in the Activity Calculator and contact Boston Scientific Corporation regarding the recall.
Why This Matters The Class II recall affects radiological image processing software used in medical procedures across the United States.
Source FDA recall Z-2771-2026, Boston Scientific Corporation, Maple Grove, MN.
Original source: FDA Official Notice ↗
Related FDA Recalls
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Similar body length
Nearest notices by article body length (1,265 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 12, 2026.
Frequently Asked Questions
Common questions about this FDA recall.