Z-2771-2026Class II

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

Name: Z-2771-2026 Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image...
Creator: Boston Scientific Corporation
Published: 2026-06-19
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2026-06-19 / Open, Classified / root cause: design

FDA source

Boston Scientific Corporation began a recall of Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System on 2026-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2771-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-06-19
Posted: 2026-07-22
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Product code: LLZ System, Image Processing, Radiological
Reason for 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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."
Quantity in commerce: 68 units
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 codes and lots: UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2771-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2771-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-22

Product code LLZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)