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2026 data FDA MAUDE openFDA FDA Class II

Temporary Carotid Catheter For Embolic Capture

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 Temporary Carotid Catheter For Embolic Capt… LIGHT-BOOK · MAUDE

#306 of 1000 · 5,311 reports · 2004–2026

  • BOOK 5,311 reports
  • RANK #306 of 1000
  • DEATH 112 death-typed
  • INJ 3,335 injury-typed
  • MALF 1,842 malfunction
  • SPAN 2004–2026
  • PEAK 2025: 410
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented (29 report gap)

Temporary Carotid Catheter For Embolic Capture sits #306 of 1000 among tracked device types with 5,311 MAUDE reports spanning 2004–2026. 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 run above the device-type norm

Temporary Carotid Catheter For Embolic Capt… carries 62.8% INJURY-coded reports, 32.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.1% corpus 1.5% · above corpus mean (+0.6 pp)
  • INJ 62.8% corpus 30.3% · above corpus mean (+32.5 pp)
  • MALF 34.7% corpus 64.8% · below corpus mean (-30.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 31% of coded problems · Lead manufacturer CORDIS CORPORATION accounts for 35% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Temporary Carotid Catheter For Embolic Capt… in the event-volume neighbourhood

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

reports

What this shows Temporary Carotid Catheter For Embolic Capture carries 5,311 MAUDE reports, ranked #306 of 1000.

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

Event Types

Injury 3,335 (62.8%)
Malfunction 1,842 (34.7%)
Death 112 (2.1%)
Other 12 (0.2%)
10 (0.2%)

Patient Outcomes

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

Required Intervention 1,999 (31.9%)
1,902 (30.3%)
Hospitalization 488 (7.8%)
R 477 (7.6%)
Other 374 (6.0%)
Disability 222 (3.5%)
L 214 (3.4%)
S 211 (3.4%)
Life Threatening 176 (2.8%)
Death 129 (2.1%)
H 47 (0.7%)
O 32 (0.5%)
D 3 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,790
Difficult to Remove 829
Improper or Incorrect Procedure or Method 305
Material Separation 287
Unknown (for use when the device problem is not known) 272
Detachment of Device or Device Component 231
Break 218
Retraction Problem 202
Physical Resistance 199
Difficult to Insert 182
Other (for use when an appropriate device code cannot be identified) 173
Detachment Of Device Component 166
Stretched 153
Difficult to Advance 132
Migration or Expulsion of Device 118
Deformation Due to Compressive Stress 103
Failure to Advance 97
Material Deformation 81
Unraveled Material 76
Entrapment of Device 73

Yearly Trend

04
2004: 2
05
2005: 2
06
2006: 70
07
2007: 119
08
2008: 368
09
2009: 343
10
2010: 294
11
2011: 304
12
2012: 261
13
2013: 258
14
2014: 199
15
2015: 148
16
2016: 148
17
2017: 141
18
2018: 158
19
2019: 233
20
2020: 238
21
2021: 327
22
2022: 326
23
2023: 354
24
2024: 398
25
2025: 410
26
2026: 210

Reports in 2025 (410) held close to the prior two-year average of 376.

Related Entities for Temporary Carotid Catheter For Embolic Capture

Top Manufacturers

CORDIS CORPORATION 1,044
AV-TEMECULA-CT 674
COVIDIEN 542
ABBOTT VASCULAR 487
ABBOTT VASCULAR INC. 260

Event Locations

3,654 (68.8%)
I 1,296 (24.4%)
OTHER 257 (4.8%)
HOSPITAL 74 (1.4%)
UNKNOWN 19 (0.4%)
NO INFORMATION 11 (0.2%)

Compare CORDIS CORPORATION vs AV-TEMECULA-CT →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Temporary Carotid Catheter For Embolic Capt…: 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 (5,311 here).

Prosthesis 5,340 Folders And Injectors, Intraocular Lens 5,350 System, X-Ray, Tomography, Computed 5,243 Sterilizer, Chemical 5,242

Similar death-typed counts

Nearest other device types by death-typed report count (112 here), distinct from the volume row.

Gas-Machine, Anesthesia 112 Extractor, Vacuum, Fetal 111 Absorbable Coronary Drug-Eluting Stent 110 Rod 115

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

Disclaimer: MAUDE figures for Temporary Carotid Catheter For Embolic Capt… 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 Temporary Carotid Catheter For Embolic Capt…; 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.