2026 data FDA MAUDE openFDA

Catheter For Crossing Total Occlusions

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 Catheter For Crossing Total Occlusions LIGHT-BOOK · MAUDE

#586 of 1000 · 1,293 reports · 2013–2026

  • BOOK 1,293 reports
  • RANK #586 of 1000
  • DEATH 2 death-typed
  • INJ 127 injury-typed
  • MALF 1,163 malfunction
  • SPAN 2013–2026
  • PEAK 2017: 211
  • PHOTO Implant

Nearest event-volume peer: Implant, Hearing, Active, Middle Ear, Partially Implanted (5 report gap)

Catheter For Crossing Total Occlusions sits #586 of 1000 among tracked device types with 1,293 MAUDE reports spanning 2013–2026. 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 0.2% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 9.8% corpus 30.4% · below corpus mean (-20.6 pp)
  • MALF 89.9% corpus 64.5% · above corpus mean (+25.4 pp)

Lead product-problem code Material Separation is 32% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 85% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .

Catheter For Crossing Total Occlusions in the event-volume neighbourhood

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

reports

What this shows Catheter For Crossing Total Occlusions carries 1,293 MAUDE reports, ranked #586 of 1000.

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

Event Types

Malfunction 1,163 (89.9%)
Injury 127 (9.8%)
Death 2 (0.2%)
1 (0.1%)

Patient Outcomes

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

1,014 (76.2%)
Other 150 (11.3%)
Required Intervention 92 (6.9%)
R 27 (2.0%)
Life Threatening 17 (1.3%)
Hospitalization 11 (0.8%)
L 9 (0.7%)
H 4 (0.3%)
O 3 (0.2%)
S 2 (0.2%)
Death 2 (0.2%)

Top Product Problems

Material Separation 596
Detachment of Device or Device Component 319
Fracture 129
Device-Device Incompatibility 128
Retraction Problem 104
Break 77
Material Deformation 75
Material Twisted/Bent 62
Material Split, Cut or Torn 58
Failure to Advance 56
Activation Problem 45
Difficult to Remove 42
Adverse Event Without Identified Device or Use Problem 33
Leak/Splash 27
Material Frayed 25
Torn Material 25
Entrapment of Device 23
Peeled/Delaminated 22
Material Puncture/Hole 20
Overheating of Device 20

Yearly Trend

13
2013: 3
14
2014: 10
15
2015: 12
16
2016: 26
17
2017: 211
18
2018: 97
19
2019: 83
20
2020: 129
21
2021: 189
22
2022: 156
23
2023: 71
24
2024: 92
25
2025: 182
26
2026: 32

Related Entities for Catheter For Crossing Total Occlusions

Event Locations

I 696 (53.8%)
576 (44.5%)
NO INFORMATION 11 (0.9%)
HOSPITAL 10 (0.8%)

Compare BARD PERIPHERAL VASCULAR, INC. vs CORDIS CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter For Crossing Total Occlusions, 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 (1,293 here).

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter For Crossing Total Occlusions 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 For Crossing Total Occlusions; 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.