FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
- Recall number
- Z-2771-2026
- Recalling firm
- Boston Scientific Corporation
- Product
- Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
- Status
- Open, Classified
- Initiated
- 2026-06-19
- Posted
- 2026-07-22
- Terminated
- not on file
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
- 510(k) numbers
- K252547, K260479
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28