CLASS II ONGOING Device recall · Reported 29 Jul 2026 · FDA Enforcement Report
TheraSphere 360 Y-90 Management Platform recalled by Boston Scientific
Boston Scientific is recalling TheraSphere 360 Y-90 Management Platform, distributed nationwide in the US. The recall was initiated on 19 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2771-2026
- FDA event ID
- 99236
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jun 2026
- FDA classified
- 22 Jul 2026
- Reported
- 29 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 19 Jun 2026 | Recall initiated by company | |
| 22 Jul 2026 | Classified by FDA | +33 days |
| 29 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing System.
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaLouisianaMassachusettsMinnesotaNebraskaNew YorkOhioOklahomaOregonSouth CarolinaSouth DakotaTennessee
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 00191506068264, All released software versions (V1.1.2, V1.2.1, V1.2.2. V2.0.1, V2.0.2)
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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