2026 data FDA MAUDE openFDA FDA Class II

Guide, Wire, Catheter, 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 §870.1330 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Guide, Wire, Catheter, Neurovasculature LIGHT-BOOK · MAUDE

#797 of 1000 · 657 reports · 1995–2026

  • BOOK 657 reports
  • RANK #797 of 1000
  • DEATH 15 death-typed
  • INJ 176 injury-typed
  • MALF 464 malfunction
  • SPAN 1995–2026
  • PEAK 2025: 137
  • PHOTO Instruments

Nearest event-volume peer: Instruments, Dental Hand (1 report gap)

Guide, Wire, Catheter, Neurovasculature sits #797 of 1000 among tracked device types with 657 MAUDE reports spanning 1995–2026. 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

Guide, Wire, Catheter, Neurovasculature carries 70.6% MALFUNCTION-coded reports, 5.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 26.8% corpus 30.3% · below corpus mean (-3.5 pp)
  • MALF 70.6% corpus 64.8% · above corpus mean (+5.8 pp)

Lead product-problem code Fracture is 36% of coded problems · Lead manufacturer MICROVENTION, INC accounts for 52% of manufacturer-tagged reports · Top event location is 86% of location-tagged rows .

Guide, Wire, Catheter, Neurovasculature in the event-volume neighbourhood

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

reports

What this shows Guide, Wire, Catheter, Neurovasculature carries 657 MAUDE reports, ranked #797 of 1000.

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

Event Types

Malfunction 464 (70.6%)
Injury 176 (26.8%)
Death 15 (2.3%)
2 (0.3%)

Patient Outcomes

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

373 (53.7%)
Other 142 (20.5%)
Required Intervention 84 (12.1%)
R 21 (3.0%)
O 18 (2.6%)
Life Threatening 13 (1.9%)
Death 12 (1.7%)
H 9 (1.3%)
Hospitalization 7 (1.0%)
Disability 6 (0.9%)
D 5 (0.7%)
L 3 (0.4%)
Invalid Data 1 (0.1%)

Top Product Problems

Fracture 240
Peeled/Delaminated 142
Break 129
Adverse Event Without Identified Device or Use Problem 41
Failure to Advance 26
Detachment of Device or Device Component 21
Insufficient Device Problem Information 15
Material Fragmentation 8
No Apparent Adverse Event 8
Material Separation 6
Material Split, Cut or Torn 6
Detachment Of Device Component 4
Delamination 3
Inaccurate Information 3
Incomplete or Missing Packaging 3
Mechanical Jam 3
Entrapment of Device 2
Material Deformation 2
Solder Joint Fracture 2
Stretched 2

Yearly Trend

95
1995: 1
01
2001: 1
06
2006: 1
08
2008: 1
12
2012: 2
13
2013: 2
15
2015: 5
16
2016: 3
17
2017: 15
18
2018: 11
19
2019: 12
20
2020: 18
21
2021: 39
22
2022: 92
23
2023: 91
24
2024: 95
25
2025: 137
26
2026: 131

Reports rose to 137 in 2025, up from an average of 93 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Guide, Wire, Catheter, Neurovasculature

Event Locations

567 (86.3%)
I 78 (11.9%)
HOSPITAL 11 (1.7%)
INVALID DATA 1 (0.2%)

Compare MICROVENTION, INC vs MICROVENTION, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Guide, Wire, Catheter, 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 (657 here).

Similar death-typed counts

Nearest other device types by death-typed report count (15 here), distinct from the volume row.

Disclaimer: MAUDE figures for Guide, Wire, Catheter, 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 Guide, Wire, Catheter, 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.