Catheter, Flow Directed
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 §870.1240 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Catheter, Flow Directed LIGHT-BOOK · MAUDE
#326 of 1000 · 4,863 reports · 1992–2026
- BOOK 4,863 reports
- RANK #326 of 1000
- DEATH 139 death-typed
- INJ 641 injury-typed
- MALF 3,894 malfunction
- SPAN 1992–2026
- PEAK 2008: 400
- PHOTO Lenses
Nearest event-volume peer: Lenses, Soft Contact, Daily Wear (5 report gap)
Catheter, Flow Directed sits #326 of 1000 among tracked device types with 4,863 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, Flow Directed carries 13.2% INJURY-coded reports, 17.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 2.9% corpus 1.5% · above corpus mean (+1.4 pp)
- INJ 13.2% corpus 30.3% · below corpus mean (-17.1 pp)
- MALF 80.1% corpus 64.8% · above corpus mean (+15.2 pp)
Lead product-problem code Pacing Problem is 11% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 39% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .
Catheter, Flow Directed in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Accessories
Accessories, Implant, Dental, Endosseous
4,902 reports
- Biopsy Needle
Biopsy Needle
4,892 reports
- Lavage, Jet
Lavage, Jet
4,888 reports
- Lenses
Lenses, Soft Contact, Daily Wear
4,868 reports
- Catheter (this)
Catheter, Flow Directed
4,863 reports
- Cement
Cement, Bone, Vertebroplasty
4,809 reports
What this shows Catheter, Flow Directed carries 4,863 MAUDE reports, ranked #326 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 (268) held close to the prior two-year average of 228.
Related Entities for Catheter, Flow Directed
Top Manufacturers
Event Locations
Compare EDWARDS LIFESCIENCES, PR vs EDWARDS LIFESCIENCES PR →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Catheter, Flow Directed: 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 (4,863 here).
Similar death-typed counts
Nearest other device types by death-typed report count (139 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Catheter, Flow Directed 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, Flow Directed; 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.