2026 data FDA MAUDE openFDA FDA Class II

Catheter, Thrombus Retriever

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).

FDA MAUDE casebook

openFDA event book Catheter, Thrombus Retriever LIGHT-BOOK · MAUDE

#235 of 1000 · 8,617 reports · 2004–2026

  • BOOK 8,617 reports
  • RANK #235 of 1000
  • DEATH 896 death-typed
  • INJ 3,462 injury-typed
  • MALF 4,225 malfunction
  • SPAN 2004–2026
  • PEAK 2023: 711
  • PHOTO Stent, Carotid

Nearest event-volume peer: Stent, Carotid (32 report gap)

Catheter, Thrombus Retriever sits #235 of 1000 among tracked device types with 8,617 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 →

Malfunction reports sit below the device-type norm

Catheter, Thrombus Retriever carries 49.0% MALFUNCTION-coded reports, 15.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 10.4% corpus 1.5% · above corpus mean (+8.9 pp)
  • INJ 40.2% corpus 30.3% · above corpus mean (+9.9 pp)
  • MALF 49.0% corpus 64.8% · below corpus mean (-15.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 29% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 68% of manufacturer-tagged reports · Top event location is 59% of location-tagged rows .

Catheter, Thrombus Retriever in the event-volume neighbourhood

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

reports

What this shows Catheter, Thrombus Retriever carries 8,617 MAUDE reports, ranked #235 of 1000.

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

Event Types

Malfunction 4,225 (49.0%)
Injury 3,462 (40.2%)
Death 896 (10.4%)
Other 29 (0.3%)
5 (0.1%)

Patient Outcomes

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

4,233 (43.5%)
Other 1,529 (15.7%)
Required Intervention 1,091 (11.2%)
Death 849 (8.7%)
R 501 (5.1%)
Life Threatening 459 (4.7%)
O 269 (2.8%)
Hospitalization 232 (2.4%)
Disability 178 (1.8%)
L 125 (1.3%)
S 105 (1.1%)
H 102 (1.0%)
D 58 (0.6%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 2,884
Break 1,414
Physical Resistance/Sticking 925
Fracture 748
Material Deformation 560
Kinked 441
Insufficient Device Problem Information 397
Failure to Advance 327
Device Damaged Prior to Use 316
Stretched 314
Difficult to Remove 286
Out-Of-Box Failure 252
Material Separation 220
Physical Resistance 215
Device Operates Differently Than Expected 179
Retraction Problem 166
Difficult to Advance 141
Detachment Of Device Component 117
Material Twisted/Bent 109
Suction Problem 93

Yearly Trend

04
2004: 7
05
2005: 24
06
2006: 15
07
2007: 13
08
2008: 18
09
2009: 57
10
2010: 289
11
2011: 263
12
2012: 366
13
2013: 405
14
2014: 428
15
2015: 598
16
2016: 497
17
2017: 432
18
2018: 415
19
2019: 650
20
2020: 703
21
2021: 688
22
2022: 549
23
2023: 711
24
2024: 641
25
2025: 572
26
2026: 276

Reports in 2025 (572) held close to the prior two-year average of 676.

Related Entities for Catheter, Thrombus Retriever

Event Locations

5,079 (58.9%)
I 3,400 (39.5%)
HOSPITAL 86 (1.0%)
NO INFORMATION 50 (0.6%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare PENUMBRA, INC. vs MICRO THERAPEUTICS, INC. DBA EV3 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Thrombus Retriever: 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 (8,617 here).

Similar death-typed counts

Nearest other device types by death-typed report count (896 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Thrombus Retriever 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, Thrombus Retriever; 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.