Catheter, Steerable
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 §870.1280 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Steerable MID-BOOK · MAUDE
#183 of 1000 · 13,804 reports · 1992–2026
- BOOK 13,804 reports
- RANK #183 of 1000
- DEATH 251 death-typed
- INJ 5,006 injury-typed
- MALF 8,544 malfunction
- SPAN 1992–2026
- PEAK 2025: 4,085
- PHOTO Oximeter
Nearest event-volume peer: Oximeter (15 report gap)
Catheter, Steerable sits #183 of 1000 among tracked device types with 13,804 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, Steerable carries 36.3% INJURY-coded reports, 6.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
- INJ 36.3% corpus 30.3% · above corpus mean (+6.0 pp)
- MALF 61.9% corpus 64.8% · below corpus mean (-2.9 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 27% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 34% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .
Catheter, Steerable in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Lens
Lens, Multifocal Intraocular
14,298 reports
- Single Use On…
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
14,104 reports
- Endoscope
Endoscope, Accessories, Narrow Band Spectrum
13,919 reports
- Oximeter
Oximeter
13,819 reports
- Catheter (this)
Catheter, Steerable
13,804 reports
- Excimer Laser…
Excimer Laser System
13,777 reports
What this shows Catheter, Steerable carries 13,804 MAUDE reports, ranked #183 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 rose to 4,085 in 2025, up from an average of 1,375 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Catheter, Steerable
Top Manufacturers
Event Locations
Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC CRYOCATH LP →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Steerable: 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 (13,804 here).
Similar death-typed counts
Nearest other device types by death-typed report count (251 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Steerable 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, Steerable; 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.