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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.1250 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Catheter For Crossing Total Occlusions LIGHT-BOOK · MAUDE

#592 of 1000 · 1,370 reports · 2013–2026

  • BOOK 1,370 reports
  • RANK #592 of 1000
  • DEATH 2 death-typed
  • INJ 130 injury-typed
  • MALF 1,237 malfunction
  • SPAN 2013–2026
  • PEAK 2017: 211
  • PHOTO Screw

Nearest event-volume peer: Screw, Fixation, Bone, Non-Spinal, Metallic (10 report gap)

Catheter For Crossing Total Occlusions sits #592 of 1000 among tracked device types with 1,370 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 →

Malfunction reports run above the device-type norm

Catheter For Crossing Total Occlusions carries 90.3% MALFUNCTION-coded reports, 25.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.1% corpus 1.5% · below corpus mean (-1.4 pp)
  • INJ 9.5% corpus 30.3% · below corpus mean (-20.8 pp)
  • MALF 90.3% corpus 64.8% · above corpus mean (+25.5 pp)

Lead product-problem code Material Separation is 31% of coded problems · Lead manufacturer BARD PERIPHERAL VASCULAR, INC. accounts for 85% of manufacturer-tagged reports · Top event location I is 51% 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 1,370 MAUDE reports, ranked #592 of 1000.

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

Event Types

Malfunction 1,237 (90.3%)
Injury 130 (9.5%)
Death 2 (0.1%)
1 (0.1%)

Patient Outcomes

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

1,092 (77.2%)
Other 150 (10.6%)
Required Intervention 94 (6.6%)
R 27 (1.9%)
Life Threatening 18 (1.3%)
Hospitalization 12 (0.8%)
L 9 (0.6%)
H 4 (0.3%)
O 4 (0.3%)
S 2 (0.1%)
Death 2 (0.1%)

Top Product Problems

Material Separation 639
Detachment of Device or Device Component 333
Fracture 137
Device-Device Incompatibility 136
Retraction Problem 112
Material Deformation 91
Break 89
Material Twisted/Bent 64
Failure to Advance 62
Material Split, Cut or Torn 61
Activation Problem 45
Difficult to Remove 45
Adverse Event Without Identified Device or Use Problem 36
Leak/Splash 33
Entrapment of Device 29
Peeled/Delaminated 26
Material Frayed 25
Torn Material 25
Material Puncture/Hole 21
Device Inoperable 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: 109

Reports rose to 182 in 2025, up from an average of 82 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter For Crossing Total Occlusions

Top Manufacturers

BARD PERIPHERAL VASCULAR, INC. 1,018
CORDIS CORPORATION 143
CORDIS DE MEXICO 20
BOSTON SCIENTIFIC CORPORATION 10

Event Locations

I 696 (50.8%)
653 (47.7%)
NO INFORMATION 11 (0.8%)
HOSPITAL 10 (0.7%)

Compare BARD PERIPHERAL VASCULAR, INC. vs CORDIS CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter For Crossing Total Occlusions: 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 (1,370 here).

Screw, Fixation, Bone, Non-Spinal, Metallic 1,380 Light Adjustable Lens And Light Delivery De… 1,354 Electrode 1,347 Dressing, Wound, Hydrophilic 1,397

Similar death-typed counts

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

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

Read our methodology - how this data is sourced, computed, and verified.

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.