2026 data FDA MAUDE openFDA

Catheter, Embolectomy

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, Embolectomy LIGHT-BOOK · MAUDE

#246 of 1000 · 7,486 reports · 1992–2026

  • BOOK 7,486 reports
  • RANK #246 of 1000
  • DEATH 142 death-typed
  • INJ 1,110 injury-typed
  • MALF 5,946 malfunction
  • SPAN 1992–2026
  • PEAK 2016: 796
  • PHOTO Intracranial Neurovas…

Nearest event-volume peer: Intracranial Neurovascular Stent (55 report gap)

Catheter, Embolectomy sits #246 of 1000 among tracked device types with 7,486 MAUDE reports spanning 1992–2026. 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 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 14.8% corpus 30.4% · below corpus mean (-15.6 pp)
  • MALF 79.4% corpus 64.5% · above corpus mean (+14.9 pp)

Lead product-problem code Material Rupture is 12% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 25% of manufacturer-tagged reports · Top event location I is 49% of location-tagged rows .

Catheter, Embolectomy in the event-volume neighbourhood

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

reports

What this shows Catheter, Embolectomy carries 7,486 MAUDE reports, ranked #246 of 1000.

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

Event Types

Malfunction 5,946 (79.4%)
Injury 1,110 (14.8%)
Other 250 (3.3%)
Death 142 (1.9%)
38 (0.5%)

Patient Outcomes

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

5,668 (73.6%)
Required Intervention 998 (13.0%)
Other 450 (5.8%)
R 148 (1.9%)
Death 144 (1.9%)
Hospitalization 140 (1.8%)
Life Threatening 64 (0.8%)
L 29 (0.4%)
O 18 (0.2%)
S 17 (0.2%)
Disability 14 (0.2%)
H 7 (0.1%)
D 2 (0.0%)
Congenital Anomaly 2 (0.0%)
Invalid Data 2 (0.0%)

Top Product Problems

Material Rupture 686
Break 677
Aspiration Issue 477
Device Displays Incorrect Message 451
Material Deformation 451
Adverse Event Without Identified Device or Use Problem 435
Material Fragmentation 375
Detachment of Device or Device Component 224
Physical Resistance/Sticking 220
Material Separation 219
Kinked 203
Deflation Problem 194
Leak/Splash 173
Device Damaged Prior to Use 171
Suction Problem 162
Display or Visual Feedback Problem 123
Physical Resistance 120
Failure to Advance 114
Burst Container or Vessel 110
Entrapment of Device 109

Yearly Trend

92
1992: 9
93
1993: 13
94
1994: 12
95
1995: 12
96
1996: 24
97
1997: 71
98
1998: 99
99
1999: 67
00
2000: 28
01
2001: 57
02
2002: 30
03
2003: 56
04
2004: 60
05
2005: 57
06
2006: 75
07
2007: 167
08
2008: 134
09
2009: 124
10
2010: 136
11
2011: 163
12
2012: 200
13
2013: 150
14
2014: 192
15
2015: 266
16
2016: 796
17
2017: 770
18
2018: 615
19
2019: 594
20
2020: 547
21
2021: 333
22
2022: 463
23
2023: 436
24
2024: 377
25
2025: 310
26
2026: 43

Related Entities for Catheter, Embolectomy

Event Locations

I 3,635 (48.6%)
2,640 (35.3%)
HOSPITAL 1,102 (14.7%)
NO INFORMATION 62 (0.8%)
INVALID DATA 14 (0.2%)
OTHER 12 (0.2%)
NOT APPLICABLE 9 (0.1%)
DIALYSIS CENTER 3 (0.0%)
RADIOLOGY DEPARTMENT 3 (0.0%)
HOME 2 (0.0%)
UNKNOWN 2 (0.0%)
CLINIC - WALK IN, OTHER 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare PENUMBRA, INC. vs EDWARDS LIFESCIENCES, PR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Embolectomy, 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 (7,486 here).

Similar death-typed counts

Nearest other device types by death-typed report count (142 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Embolectomy 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, Embolectomy; 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.