2026 data FDA MAUDE openFDA

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 MAUDE casebook

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

#455 of 1000 · 2,232 reports · 1999–2026

  • BOOK 2,232 reports
  • RANK #455 of 1000
  • DEATH 99 death-typed
  • INJ 436 injury-typed
  • MALF 1,678 malfunction
  • SPAN 1999–2026
  • PEAK 2024: 224
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Penis, Inflatable (7 report gap)

Catheter, Intravascular Occluding, Temporary sits #455 of 1000 among tracked device types with 2,232 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 →

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 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 19.5% corpus 30.4% · below corpus mean (-10.9 pp)
  • MALF 75.2% corpus 64.5% · above corpus mean (+10.7 pp)

Lead product-problem code Material Rupture is 19% of coded problems · Lead manufacturer STRYKER NEUROVASCULAR CORK accounts for 38% of manufacturer-tagged reports · Top event location is 62% 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 2,232 MAUDE reports, ranked #455 of 1000.

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

Event Types

Malfunction 1,678 (75.2%)
Injury 436 (19.5%)
Death 99 (4.4%)
Other 13 (0.6%)
6 (0.3%)

Patient Outcomes

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

1,509 (63.6%)
Required Intervention 299 (12.6%)
Other 241 (10.2%)
Death 90 (3.8%)
R 64 (2.7%)
Hospitalization 33 (1.4%)
Life Threatening 31 (1.3%)
O 25 (1.1%)
Disability 25 (1.1%)
S 20 (0.8%)
L 16 (0.7%)
D 9 (0.4%)
H 8 (0.3%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Material Rupture 291
Deflation Problem 183
Adverse Event Without Identified Device or Use Problem 159
Inflation Problem 158
Leak/Splash 146
Fluid/Blood Leak 115
Burst Container or Vessel 95
Material Puncture/Hole 62
Failure to Deflate 53
Break 44
Patient Device Interaction Problem 39
Entrapment of Device 29
Failure to Advance 23
Difficult to Remove 21
Hole In Material 18
Material Deformation 17
Device Operates Differently Than Expected 14
Difficult to Open or Close 13
Fracture 13
Difficult to Advance 12

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: 17

Related Entities for Catheter, Intravascular Occluding, Temporary

Event Locations

1,382 (61.9%)
I 755 (33.8%)
HOSPITAL 79 (3.5%)
NO INFORMATION 12 (0.5%)
OTHER 2 (0.1%)
UNKNOWN 2 (0.1%)

Compare STRYKER NEUROVASCULAR CORK vs MICROVENTION, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Intravascular Occluding, Temporary, 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 (2,232 here).

Similar death-typed counts

Nearest other device types by death-typed report count (99 here), distinct from the volume row.

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.