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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.5150 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Embolectomy LIGHT-BOOK · MAUDE
#252 of 1000 · 7,736 reports · 1992–2026
- BOOK 7,736 reports
- RANK #252 of 1000
- DEATH 143 death-typed
- INJ 1,117 injury-typed
- MALF 6,188 malfunction
- SPAN 1992–2026
- PEAK 2016: 796
- PHOTO Catheter
Nearest event-volume peer: Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring (1 report gap)
Catheter, Embolectomy sits #252 of 1000 among tracked device types with 7,736 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 →
Injury-coded reports sit below the device-type norm
Catheter, Embolectomy carries 14.4% INJURY-coded reports, 15.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
- INJ 14.4% corpus 30.3% · below corpus mean (-15.9 pp)
- MALF 80.0% corpus 64.8% · above corpus mean (+15.2 pp)
Lead product-problem code Break is 13% of coded problems · Lead manufacturer PENUMBRA, INC. accounts for 24% of manufacturer-tagged reports · Top event location I is 47% of location-tagged rows .
Catheter, Embolectomy in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Defibrillator
Defibrillator, Implantable, Dual-Chamber
7,836 reports
- System
System, Multipurpose For In Vitro Coagulation Studies
7,801 reports
- Catheter
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
7,737 reports
- Catheter (this)
Catheter, Embolectomy
7,736 reports
- Device
Device, Microtiter Diluting/Dispensing
7,712 reports
- Nasopharyngos…
Nasopharyngoscope (Flexible Or Rigid)
7,691 reports
What this shows Catheter, Embolectomy carries 7,736 MAUDE reports, ranked #252 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (310) held close to the prior two-year average of 407.
Related Entities for Catheter, Embolectomy
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Embolectomy: 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 (7,736 here).
Similar death-typed counts
Nearest other device types by death-typed report count (143 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.