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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Intravascular Occluding, Temporary

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 §870.4450 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Catheter, Intravascular Occluding, Temporary LIGHT-BOOK · MAUDE

#464 of 1000 · 2,330 reports · 1999–2026

  • BOOK 2,330 reports
  • RANK #464 of 1000
  • DEATH 101 death-typed
  • INJ 455 injury-typed
  • MALF 1,755 malfunction
  • SPAN 1999–2026
  • PEAK 2024: 224
  • PHOTO Light Source

Nearest event-volume peer: Light Source, Endoscope, Xenon Arc (2 report gap)

Catheter, Intravascular Occluding, Temporary sits #464 of 1000 among tracked device types with 2,330 MAUDE reports spanning 1999–2026. 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 sit below the device-type norm

Catheter, Intravascular Occluding, Temporary carries 19.5% INJURY-coded reports, 10.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.3% corpus 1.5% · above corpus mean (+2.8 pp)
  • INJ 19.5% corpus 30.3% · below corpus mean (-10.8 pp)
  • MALF 75.3% corpus 64.8% · above corpus mean (+10.5 pp)

Lead product-problem code Material Rupture is 17% of coded problems · Lead manufacturer STRYKER NEUROVASCULAR CORK accounts for 37% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Catheter, Intravascular Occluding, Temporary in the event-volume neighbourhood

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

reports

What this shows Catheter, Intravascular Occluding, Temporary carries 2,330 MAUDE reports, ranked #464 of 1000.

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

Event Types

Malfunction 1,755 (75.3%)
Injury 455 (19.5%)
Death 101 (4.3%)
Other 13 (0.6%)
6 (0.3%)

Patient Outcomes

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

1,581 (63.9%)
Required Intervention 314 (12.7%)
Other 247 (10.0%)
Death 92 (3.7%)
R 64 (2.6%)
Hospitalization 33 (1.3%)
Life Threatening 33 (1.3%)
O 27 (1.1%)
Disability 25 (1.0%)
S 20 (0.8%)
L 17 (0.7%)
H 10 (0.4%)
D 9 (0.4%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Rupture 366
Deflation Problem 325
Leak/Splash 253
Inflation Problem 224
Adverse Event Without Identified Device or Use Problem 195
Burst Container or Vessel 134
Fluid/Blood Leak 125
Break 86
Material Puncture/Hole 70
Difficult to Remove 60
Failure to Deflate 54
Patient Device Interaction Problem 44
Entrapment of Device 34
Failure to Advance 33
Material Deformation 32
Replace 31
Hole In Material 30
Stretched 30
Balloon rupture 29
Detachment Of Device Component 29

Yearly Trend

99
1999: 6
00
2000: 8
01
2001: 13
02
2002: 18
03
2003: 28
04
2004: 36
05
2005: 27
06
2006: 18
07
2007: 25
08
2008: 26
09
2009: 25
10
2010: 35
11
2011: 92
12
2012: 53
13
2013: 76
14
2014: 100
15
2015: 90
16
2016: 71
17
2017: 157
18
2018: 107
19
2019: 139
20
2020: 157
21
2021: 158
22
2022: 148
23
2023: 181
24
2024: 224
25
2025: 197
26
2026: 115

Reports in 2025 (197) held close to the prior two-year average of 203.

Related Entities for Catheter, Intravascular Occluding, Temporary

Top Manufacturers

STRYKER NEUROVASCULAR CORK 378
MICRO THERAPEUTICS, INC. DBA EV3 176
MICROVENTION, INC. 171
EV3 NEUROVASCULAR 157
W. L. GORE & ASSOCIATES, INC. 71
BOSTON SCIENTIFIC CORPORATION 66

Event Locations

1,479 (63.5%)
I 755 (32.4%)
HOSPITAL 80 (3.4%)
NO INFORMATION 12 (0.5%)
OTHER 2 (0.1%)
UNKNOWN 2 (0.1%)

Compare STRYKER NEUROVASCULAR CORK vs MICRO THERAPEUTICS, INC. DBA EV3 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Intravascular Occluding, Temporary: 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 (2,330 here).

Light Source, Endoscope, Xenon Arc 2,332 Prosthesis, Knee, Hemi-, Femoral 2,314 Circuit, Breathing 2,347 Catheter, Peritoneal, Long-Term Indwelling 2,355

Similar death-typed counts

Nearest other device types by death-typed report count (101 here), distinct from the volume row.

Mesh 100 Catheter, Septostomy 104 Neurological Stereotaxic Instrument 104 Shockwave Intravascular Lithotripsy System 98

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

Disclaimer: MAUDE figures for Catheter, Intravascular Occluding, Temporary 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, Intravascular Occluding, Temporary; 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.