2026 data FDA MAUDE openFDA

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 MAUDE casebook

openFDA event book Stylet, Catheter LIGHT-BOOK · MAUDE

#603 of 1000 · 1,212 reports · 1992–2026

  • BOOK 1,212 reports
  • RANK #603 of 1000
  • DEATH 69 death-typed
  • INJ 954 injury-typed
  • MALF 185 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 154
  • PHOTO Lamp, Surgical

Nearest event-volume peer: Lamp, Surgical (5 report gap)

Stylet, Catheter sits #603 of 1000 among tracked device types with 1,212 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 5.7% corpus 1.5% · above corpus mean (+4.2 pp)
  • INJ 78.7% corpus 30.4% · above corpus mean (+48.3 pp)
  • MALF 15.3% corpus 64.5% · below corpus mean (-49.2 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 61% of coded problems · Lead manufacturer MEDTRONIC, INC. accounts for 61% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Stylet, Catheter in the event-volume neighbourhood

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

reports

What this shows Stylet, Catheter carries 1,212 MAUDE reports, ranked #603 of 1000.

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

Event Types

Injury 954 (78.7%)
Malfunction 185 (15.3%)
Death 69 (5.7%)
Other 4 (0.3%)

Patient Outcomes

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

R 385 (19.7%)
Other 349 (17.8%)
L 313 (16.0%)
Hospitalization 310 (15.8%)
Required Intervention 167 (8.5%)
164 (8.4%)
Life Threatening 149 (7.6%)
Death 68 (3.5%)
O 22 (1.1%)
D 12 (0.6%)
H 12 (0.6%)
Disability 4 (0.2%)
S 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 538
Break 118
Mechanical Problem 52
Packaging Problem 32
Material Separation 31
Device Operates Differently Than Expected 20
Difficult to Remove 19
Insufficient Information 12
Activation, Positioning or Separation Problem 6
Detachment Of Device Component 6
Detachment of Device or Device Component 6
Device Inoperable 6
Fracture 6
Material Integrity Problem 6
Appropriate Term/Code Not Available 5
Retraction Problem 5
Contamination 4
Device Dislodged or Dislocated 3
Entrapment of Device 3
Malposition of Device 3

Yearly Trend

92
1992: 2
06
2006: 1
08
2008: 5
09
2009: 4
10
2010: 54
11
2011: 28
12
2012: 40
13
2013: 53
14
2014: 67
15
2015: 66
16
2016: 56
17
2017: 63
18
2018: 40
19
2019: 82
20
2020: 92
21
2021: 97
22
2022: 94
23
2023: 82
24
2024: 116
25
2025: 154
26
2026: 16

Related Entities for Stylet, Catheter

Event Locations

694 (57.3%)
I 449 (37.0%)
HOSPITAL 67 (5.5%)
NO INFORMATION 2 (0.2%)

Compare MEDTRONIC, INC. vs MEDTRONIC PUERTO RICO VILLALBA →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Stylet, Catheter, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,212 here).

Similar death-typed counts

Nearest other device types by death-typed report count (69 here), distinct from the volume row.

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.