Shockwave Intravascular Lithotripsy System
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 Shockwave Intravascular Lithotripsy System LIGHT-BOOK · MAUDE
#931 of 1000 · 445 reports · 2021–2026
- BOOK 445 reports
- RANK #931 of 1000
- DEATH 98 death-typed
- INJ 253 injury-typed
- MALF 92 malfunction
- SPAN 2021–2026
- PEAK 2025: 130
- PHOTO Shunt
Nearest event-volume peer: Shunt, Portosystemic, Endoprosthesis (1 report gap)
Shockwave Intravascular Lithotripsy System sits #931 of 1000 among tracked device types with 445 MAUDE reports spanning 2021–2026. 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
Shockwave Intravascular Lithotripsy System carries 20.7% MALFUNCTION-coded reports, 44.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 22.0% corpus 1.5% · above corpus mean (+20.5 pp)
- INJ 56.9% corpus 30.3% · above corpus mean (+26.6 pp)
- MALF 20.7% corpus 64.8% · below corpus mean (-44.2 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 45% of coded problems · Lead manufacturer UNKNOWN accounts for 100% of manufacturer-tagged reports · Top event location is 87% of location-tagged rows .
Shockwave Intravascular Lithotripsy System in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Catheter
Catheter, Recording, Electrode, Reprocessed
449 reports
- Shockwave Int… (this)
Shockwave Intravascular Lithotripsy System
445 reports
- Shunt
Shunt, Portosystemic, Endoprosthesis
444 reports
- System
System, X-Ray, Mammographic
443 reports
- Biliary Cathe…
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
441 reports
- Inhibitor
Inhibitor, Peridural Fibrosis (Adhesion Barrier)
440 reports
What this shows Shockwave Intravascular Lithotripsy System carries 445 MAUDE reports, ranked #931 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 rose to 130 in 2025, up from an average of 88 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Shockwave Intravascular Lithotripsy System
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Shockwave Intravascular Lithotripsy System: 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 (445 here).
Similar death-typed counts
Nearest other device types by death-typed report count (98 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Shockwave Intravascular Lithotripsy System 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 Shockwave Intravascular Lithotripsy System; 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.