Devices › Microspheres radionuclide
Device brand name · Radioactive microspheres
Therasphere: medical device reports filed with FDA
379 reports name it, 2001–2021. Manufacturer given most often on reports: Biocompatibles UK. Product code NAW.
- 379
- device reports naming the brand
- 0% of all MAUDE reports · about 15 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 0.5%
- classified as malfunction
- 4.8% across the product code
- 34.8%
- classified as death, as reported
- 132 reports · not verified by FDA
379 medical device reports received by FDA name the brand "Therasphere" (radioactive microspheres); the manufacturer given most often on reports is Biocompatibles UK; received from September 2001 to May 2021. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (50.7%), death (34.8%) and other (6.6%); across all microspheres radionuclide reports (product code NAW) death is recorded in 24.4% and malfunction in 4.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (12.9%), reaction (5%) and device remains implanted (4.2%). The patient problems coded most often are death, liver damage/dysfunction and abdominal pain. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
No report naming Therasphere was received in the five years to August 2026; the latest was received in May 2021.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 581 reports carrying product code NAW. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Insufficient device problem information | 49 | 12.9% | 12% |
| Reactiona reaction, type not specified | 19 | 5% | 0% |
| Device remains implanted | 16 | 4.2% | 0% |
| Device operates differently than expectedthe device behaved unexpectedly | 10 | 2.6% | 2.1% |
| Patient-device incompatibilitythe device did not suit the patient | 8 | 2.1% | 1.7% |
| Activation, positioning or separation problem | 5 | 1.3% | 0.9% |
| Improper or incorrect procedure or method | 4 | 1.1% | 1.2% |
| Malposition of device | 3 | 0.8% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 3 | 0.8% | 0% |
| Fluid/blood leak | 2 | 0.5% | 0.5% |
| Inaccurate delivery | 2 | 0.5% | 0.5% |
| Seal, defective | 2 | 0.5% | 0% |
| Therapy delivered to incorrect body area | 2 | 0.5% | 0.5% |
| Backflow | 1 | 0.3% | 0.2% |
| Delivery system failure | 1 | 0.3% | 0.2% |
| Difficult to position | 1 | 0.3% | 0% |
| Dislodged | 1 | 0.3% | 0% |
| Failure to deliverthe device did not deliver the dose or item | 1 | 0.3% | 0% |
| High test results | 1 | 0.3% | 0.2% |
| Inadequate instructions for healthcare professional | 1 | 0.3% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 117 | 30.9% |
| Liver damage/dysfunction | 81 | 21.4% |
| Abdominal painstomach or belly pain | 61 | 16.1% |
| Ascitesfluid in the abdomen | 59 | 15.6% |
| Therapy/non-surgical treatment, additional | 59 | 15.6% |
| Hospitalization required | 51 | 13.5% |
| Treatment with medication(s) | 45 | 11.9% |
| Vomitingbeing sick | 42 | 11.1% |
| Nauseafeeling sick | 37 | 9.8% |
| Other (for use when an appropriate patient code cannot be identified) | 30 | 7.9% |
| Test result | 23 | 6.1% |
| Encephalopathy | 22 | 5.8% |
| Fatiguetiredness | 22 | 5.8% |
| Fever | 21 | 5.5% |
| Painpain, site not specified | 19 | 5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Therasphere | Product code NAW | All MAUDE reports |
|---|---|---|---|
| Reports | 379 | 581 | 26,136,888 |
| Share of that pool | — | 65.2% | 0% |
| Classified as death, per 1,000 reports | 348 | 244 | 9 |
| Classified as injury | 50.7% | 62.8% | 36.2% |
| Classified as malfunction | 0.5% | 4.8% | 62.3% |
| Filed by the manufacturer | 86.8% | 97.1% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Questions about Therasphere reports
How many FDA reports name Therasphere?
379 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (50.7%), death (34.8%) and other (6.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (12.9%), reaction (5%), device remains implanted (4.2%), device operates differently than expected (2.6%) and patient-device incompatibility (2.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (86.8%) and voluntary reports (11.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Therasphere was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.