Wire, Guide, Catheter
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 Wire, Guide, Catheter MID-BOOK · MAUDE
#98 of 1000 · 33,688 reports · 1992–2026
- BOOK 33,688 reports
- RANK #98 of 1000
- DEATH 927 death-typed
- INJ 13,127 injury-typed
- MALF 19,329 malfunction
- SPAN 1992–2026
- PEAK 2024: 2,210
- PHOTO Stents
Nearest event-volume peer: Stents, Drains And Dilators For The Biliary Ducts (33 report gap)
Wire, Guide, Catheter sits #98 of 1000 among tracked device types with 33,688 MAUDE reports spanning 1992–2026. 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 →
Injury-coded reports run above the device-type norm
Wire, Guide, Catheter carries 39.0% INJURY-coded reports, 8.7pp 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 (+1.2 pp)
- INJ 39.0% corpus 30.3% · above corpus mean (+8.7 pp)
- MALF 57.4% corpus 64.8% · below corpus mean (-7.5 pp)
Lead product-problem code Difficult to Remove is 13% of coded problems · Lead manufacturer AV-TEMECULA-CT accounts for 24% of manufacturer-tagged reports · Top event location is 55% of location-tagged rows .
Wire, Guide, Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Wire (this)
Wire, Guide, Catheter
33,688 reports
- Stents
Stents, Drains And Dilators For The Biliary Ducts
33,655 reports
- Pump
Pump, Infusion, Elastomeric
33,422 reports
- Detector And…
Detector And Alarm, Arrhythmia
33,370 reports
- Pump
Pump, Infusion, Pca
32,663 reports
- Prosthesis
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
32,652 reports
What this shows Wire, Guide, Catheter carries 33,688 MAUDE reports, ranked #98 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (2,201) held close to the prior two-year average of 2,139.
Related Entities for Wire, Guide, Catheter
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Wire, Guide, Catheter: 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 (33,688 here).
Similar death-typed counts
Nearest other device types by death-typed report count (927 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Wire, Guide, Catheter 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 Wire, Guide, Catheter; 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.