Catheter, Electrode Recording, Or Probe, Electrode Recording
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 §870.1220 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter LIGHT-BOOK · MAUDE
#232 of 1000 · 8,756 reports · 1992–2026
- BOOK 8,756 reports
- RANK #232 of 1000
- DEATH 307 death-typed
- INJ 4,128 injury-typed
- MALF 4,269 malfunction
- SPAN 1992–2026
- PEAK 2018: 723
- PHOTO Lens
Nearest event-volume peer: Lens, Guide, Intraocular (70 report gap)
Catheter, Electrode Recording, Or Probe, Electrode Recording sits #232 of 1000 among tracked device types with 8,756 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
Catheter carries 47.1% INJURY-coded reports, 16.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
- INJ 47.1% corpus 30.3% · above corpus mean (+16.9 pp)
- MALF 48.8% corpus 64.8% · below corpus mean (-16.1 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 37% of coded problems · Lead manufacturer BIOSENSE WEBSTER INC accounts for 18% of manufacturer-tagged reports · Top event location is 51% of location-tagged rows .
Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Percutaneous…
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation
8,981 reports
- Catheter
Catheter, Continuous Flush
8,965 reports
- Catheter (this)
Catheter, Electrode Recording, Or Probe, Electrode Recording
8,756 reports
- Lens
Lens, Guide, Intraocular
8,686 reports
- Stent, Carotid
Stent, Carotid
8,649 reports
- Catheter
Catheter, Thrombus Retriever
8,617 reports
What this shows Catheter, Electrode Recording, Or Probe, Electrode Recording carries 8,756 MAUDE reports, ranked #232 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 (514) held close to the prior two-year average of 654.
Related Entities for Catheter, Electrode Recording, Or Probe, Electrode Recording
Top Manufacturers
Event Locations
Compare BIOSENSE WEBSTER INC 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: 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 (8,756 here).
Similar death-typed counts
Nearest other device types by death-typed report count (307 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for 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 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.