Stylet, 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 §870.1380 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Stylet, Catheter LIGHT-BOOK · MAUDE
#608 of 1000 · 1,275 reports · 1992–2026
- BOOK 1,275 reports
- RANK #608 of 1000
- DEATH 77 death-typed
- INJ 1,007 injury-typed
- MALF 187 malfunction
- SPAN 1992–2026
- PEAK 2025: 154
- PHOTO Bone Mill
Nearest event-volume peer: Bone Mill (2 report gap)
Stylet, Catheter sits #608 of 1000 among tracked device types with 1,275 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 →
Malfunction reports sit below the device-type norm
Stylet, Catheter carries 14.7% MALFUNCTION-coded reports, 50.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 6.0% corpus 1.5% · above corpus mean (+4.5 pp)
- INJ 79.0% corpus 30.3% · above corpus mean (+48.7 pp)
- MALF 14.7% corpus 64.8% · below corpus mean (-50.2 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 52% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 62% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .
Stylet, Catheter in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Solid State X…
Solid State X-Ray Imager (Flat Panel/Digital Imager)
1,277 reports
- Stylet (this)
Stylet, Catheter
1,275 reports
- Bone Mill
Bone Mill
1,273 reports
- Bed
Bed, Pediatric Open Hospital
1,272 reports
- Intervertebra…
Intervertebral Fusion Device With Integrated Fixation, Lumbar
1,268 reports
- Tube, Feeding
Tube, Feeding
1,266 reports
What this shows Stylet, Catheter carries 1,275 MAUDE reports, ranked #608 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 154 in 2025, up from an average of 99 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Stylet, Catheter
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Stylet, 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 (1,275 here).
Similar death-typed counts
Nearest other device types by death-typed report count (77 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Stylet, 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 Stylet, 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.