2026 data FDA MAUDE openFDA FDA Class II

Peripheral Mechanical Thrombectomy With Aspiration

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 §870.5150 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Peripheral Mechanical Thrombectomy With Asp… LIGHT-BOOK · MAUDE

#599 of 1000 · 1,318 reports · 2019–2026

  • BOOK 1,318 reports
  • RANK #599 of 1000
  • DEATH 128 death-typed
  • INJ 296 injury-typed
  • MALF 893 malfunction
  • SPAN 2019–2026
  • PEAK 2021: 322
  • PHOTO Stent

Nearest event-volume peer: Stent, Colonic, Metallic, Expandable (1 report gap)

Peripheral Mechanical Thrombectomy With Aspiration sits #599 of 1000 among tracked device types with 1,318 MAUDE reports spanning 2019–2026. 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 →

Death-coded reports run above the device-type norm

Peripheral Mechanical Thrombectomy With Asp… carries 9.7% DEATH-coded reports, 8.2pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 9.7% corpus 1.5% · above corpus mean (+8.2 pp)
  • INJ 22.5% corpus 30.3% · below corpus mean (-7.8 pp)
  • MALF 67.8% corpus 64.8% · above corpus mean (+2.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 16% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 88% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Peripheral Mechanical Thrombectomy With Asp… in the event-volume neighbourhood

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

reports

What this shows Peripheral Mechanical Thrombectomy With Aspiration carries 1,318 MAUDE reports, ranked #599 of 1000.

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

Event Types

Malfunction 893 (67.8%)
Injury 296 (22.5%)
Death 128 (9.7%)
1 (0.1%)

Patient Outcomes

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

874 (56.1%)
Required Intervention 225 (14.4%)
R 91 (5.8%)
Death 87 (5.6%)
L 77 (4.9%)
Other 57 (3.7%)
D 39 (2.5%)
Hospitalization 34 (2.2%)
H 28 (1.8%)
Life Threatening 28 (1.8%)
O 12 (0.8%)
S 3 (0.2%)
Disability 3 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 249
Break 215
Physical Resistance/Sticking 179
Material Deformation 162
Fracture 150
Entrapment of Device 90
Obstruction of Flow 66
Detachment of Device or Device Component 58
Use of Device Problem 50
Electrical /Electronic Property Problem 47
Material Separation 45
Difficult to Remove 40
Failure to Advance 40
Leak/Splash 40
Improper or Incorrect Procedure or Method 37
Connection Problem 30
Suction Problem 25
Difficult to Advance 21
Display or Visual Feedback Problem 20
Suction Failure 19

Yearly Trend

19
2019: 33
20
2020: 197
21
2021: 322
22
2022: 125
23
2023: 165
24
2024: 162
25
2025: 208
26
2026: 106

Reports in 2025 (208) held close to the prior two-year average of 164.

Related Entities for Peripheral Mechanical Thrombectomy With Aspiration

Event Locations

824 (62.5%)
I 474 (36.0%)
HOSPITAL 17 (1.3%)
NO INFORMATION 3 (0.2%)

Compare PENUMBRA, INC. vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Peripheral Mechanical Thrombectomy With Asp…: 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 (1,318 here).

Similar death-typed counts

Nearest other device types by death-typed report count (128 here), distinct from the volume row.

Disclaimer: MAUDE figures for Peripheral Mechanical Thrombectomy With Asp… 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 Peripheral Mechanical Thrombectomy With Asp…; 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.