2026 data FDA MAUDE openFDA FDA Class II

Catheter, Percutaneous, Neurovasculature

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.1250 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Catheter, Percutaneous, Neurovasculature LIGHT-BOOK · MAUDE

#539 of 1000 · 1,669 reports · 2020–2026

  • BOOK 1,669 reports
  • RANK #539 of 1000
  • DEATH 47 death-typed
  • INJ 263 injury-typed
  • MALF 1,359 malfunction
  • SPAN 2020–2026
  • PEAK 2025: 700
  • PHOTO Assay

Nearest event-volume peer: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (1 report gap)

Catheter, Percutaneous, Neurovasculature sits #539 of 1000 among tracked device types with 1,669 MAUDE reports spanning 2020–2026. 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 run above the device-type norm

Catheter, Percutaneous, Neurovasculature carries 81.4% MALFUNCTION-coded reports, 16.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.8% corpus 1.5% · above corpus mean (+1.3 pp)
  • INJ 15.8% corpus 30.3% · below corpus mean (-14.5 pp)
  • MALF 81.4% corpus 64.8% · above corpus mean (+16.6 pp)

Lead product-problem code Physical Resistance/Sticking is 40% of coded problems · Lead manufacturer MEDOS INTERNATIONAL SARL accounts for 52% of manufacturer-tagged reports · Top event location is 98% of location-tagged rows .

Catheter, Percutaneous, Neurovasculature in the event-volume neighbourhood

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

reports

What this shows Catheter, Percutaneous, Neurovasculature carries 1,669 MAUDE reports, ranked #539 of 1000.

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

Event Types

Malfunction 1,359 (81.4%)
Injury 263 (15.8%)
Death 47 (2.8%)

Patient Outcomes

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

1,208 (77.0%)
Required Intervention 76 (4.8%)
Other 63 (4.0%)
Life Threatening 56 (3.6%)
Hospitalization 50 (3.2%)
Death 45 (2.9%)
R 19 (1.2%)
L 16 (1.0%)
O 12 (0.8%)
H 9 (0.6%)
Disability 5 (0.3%)
D 4 (0.3%)
S 4 (0.3%)
C 1 (0.1%)

Top Product Problems

Physical Resistance/Sticking 824
Adverse Event Without Identified Device or Use Problem 249
Retraction Problem 234
Material Twisted/Bent 115
Crack 96
Difficult to Advance 85
Material Deformation 84
Break 77
Unintended Movement 46
Material Separation 37
No Apparent Adverse Event 29
Burst Container or Vessel 28
Fluid/Blood Leak 28
Deformation Due to Compressive Stress 26
Difficult to Remove 24
Stretched 24
Fracture 23
Deflation Problem 15
Device Damaged by Another Device 15
Material Integrity Problem 11

Yearly Trend

20
2020: 16
21
2021: 29
22
2022: 30
23
2023: 75
24
2024: 133
25
2025: 700
26
2026: 686

Reports rose to 700 in 2025, up from an average of 104 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Percutaneous, Neurovasculature

Event Locations

1,631 (97.7%)
I 31 (1.9%)
HOSPITAL 4 (0.2%)
NO INFORMATION 3 (0.2%)

Compare MEDOS INTERNATIONAL SARL vs MEDTRONIC MEXICO S. DE R.L. DE CV →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Percutaneous, Neurovasculature: 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 (1,669 here).

Similar death-typed counts

Nearest other device types by death-typed report count (47 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Percutaneous, Neurovasculature 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 Catheter, Percutaneous, Neurovasculature; 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.