FDA recall, , Moderate risk
Boston Scientific TheraSphere 360 Y-90 Management Platform
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.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation of Maple Grove, Minnesota, recalled its Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001, a Radiological Image Processing System. The recall began June 19, 2026, and was added to the FDA's Enforcement Report on July 22, 2026.
The 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.
The product was distributed nationwide in the United States, including in states such as Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia and Wyoming. The recall affects 68 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Boston Scientific TheraSphere 360 Y-90 Management Platform
- Model number
- M00139509001
- UDI-DI
- 00191506068264
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, Nebraska, New York, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin, West Virginia, Wyoming.
- Company
- Boston Scientific CorporationMaple Grove, Minnesota
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99236
- Recall number
- Z-2771-2026
- Quantity recalled
- 68 units
All recalls from Boston Scientific Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
