2026 data FDA MAUDE openFDA FDA Class III

Microspheres Radionuclide

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Microspheres Radionuclide LIGHT-BOOK · MAUDE

#845 of 1000 · 578 reports · 2003–2026

  • BOOK 578 reports
  • RANK #845 of 1000
  • DEATH 142 death-typed
  • INJ 364 injury-typed
  • MALF 26 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 77
  • PHOTO Drug-Eluting Percutan…

Nearest event-volume peer: Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter (0 report gap)

Microspheres Radionuclide sits #845 of 1000 among tracked device types with 578 MAUDE reports spanning 2003–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Malfunction reports sit below the device-type norm

Microspheres Radionuclide carries 4.5% MALFUNCTION-coded reports, 60.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 24.6% corpus 1.5% · above corpus mean (+23.1 pp)
  • INJ 63.0% corpus 30.3% · above corpus mean (+32.7 pp)
  • MALF 4.5% corpus 64.8% · below corpus mean (-60.3 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 74% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 100% of manufacturer-tagged reports · Top event location is 49% of location-tagged rows .

Microspheres Radionuclide in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Microspheres Radionuclide carries 578 MAUDE reports, ranked #845 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 364 (63.0%)
Death 142 (24.6%)
33 (5.7%)
Malfunction 26 (4.5%)
Other 13 (2.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Hospitalization 160 (19.7%)
Required Intervention 149 (18.3%)
Death 148 (18.2%)
Other 90 (11.1%)
H 78 (9.6%)
R 76 (9.3%)
O 54 (6.6%)
25 (3.1%)
L 12 (1.5%)
S 8 (1.0%)
D 7 (0.9%)
Life Threatening 5 (0.6%)
Disability 2 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 428
Insufficient Device Problem Information 70
Device Operates Differently Than Expected 12
Patient-Device Incompatibility 10
Improper or Incorrect Procedure or Method 7
Radiation Underexposure 7
Activation, Positioning or Separation Problem 5
Use of Device Problem 5
Device Contamination with Chemical or Other Material 4
Appropriate Device Problem Term/Code Not Available 3
Fluid/Blood Leak 3
Inaccurate Delivery 3
Leak/Splash 3
Malposition of Device 3
Therapy Delivered to Incorrect Body Area 3
Contamination 2
Detachment of Device or Device Component 2
Improper Flow or Infusion 2
Infusion or Flow Problem 2
Physical Resistance/Sticking 2

Yearly Trend

03
2003: 3
10
2010: 1
11
2011: 5
12
2012: 17
13
2013: 10
14
2014: 11
15
2015: 35
16
2016: 39
17
2017: 37
18
2018: 48
19
2019: 60
20
2020: 28
21
2021: 76
22
2022: 23
23
2023: 37
24
2024: 53
25
2025: 77
26
2026: 18

Reports rose to 77 in 2025, up from an average of 45 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Microspheres Radionuclide

Top Manufacturers

Event Locations

283 (49.0%)
I 281 (48.6%)
HOSPITAL 10 (1.7%)
NO INFORMATION 4 (0.7%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Microspheres Radionuclide: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (578 here).

Similar death-typed counts

Nearest other device types by death-typed report count (142 here), distinct from the volume row.

Disclaimer: MAUDE figures for Microspheres Radionuclide are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Microspheres Radionuclide; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.