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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Catheter, Flow Directed LIGHT-BOOK · MAUDE

#325 of 1000 · 4,682 reports · 1992–2026

  • BOOK 4,682 reports
  • RANK #325 of 1000
  • DEATH 139 death-typed
  • INJ 623 injury-typed
  • MALF 3,731 malfunction
  • SPAN 1992–2026
  • PEAK 2008: 400
  • PHOTO Lavage, Jet

Nearest event-volume peer: Lavage, Jet (12 report gap)

Catheter, Flow Directed sits #325 of 1000 among tracked device types with 4,682 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 3.0% corpus 1.5% · above corpus mean (+1.4 pp)
  • INJ 13.3% corpus 30.4% · below corpus mean (-17.1 pp)
  • MALF 79.7% corpus 64.5% · above corpus mean (+15.2 pp)

Lead product-problem code Pacing Problem is 13% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES, PR accounts for 39% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Catheter, Flow Directed in the event-volume neighbourhood

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

reports

What this shows Catheter, Flow Directed carries 4,682 MAUDE reports, ranked #325 of 1000.

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

Event Types

Malfunction 3,731 (79.7%)
Injury 623 (13.3%)
Death 139 (3.0%)
Other 133 (2.8%)
56 (1.2%)

Patient Outcomes

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

2,778 (57.4%)
Other 1,222 (25.2%)
Required Intervention 264 (5.5%)
Disability 133 (2.7%)
Death 126 (2.6%)
R 81 (1.7%)
Hospitalization 75 (1.5%)
Life Threatening 74 (1.5%)
L 31 (0.6%)
S 22 (0.5%)
O 16 (0.3%)
H 10 (0.2%)
Invalid Data 8 (0.2%)
D 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Pacing Problem 194
Material Rupture 155
Incorrect Measurement 154
Incorrect, Inadequate or Imprecise Result or Readings 141
Inflation Problem 111
Deflation Problem 100
Adverse Event Without Identified Device or Use Problem 89
Leak/Splash 65
Burst Container or Vessel 58
Fluid/Blood Leak 52
Appropriate Term/Code Not Available 49
Detachment of Device or Device Component 45
Difficult to Advance 36
Break 34
Failure to Capture 33
Failure to Deflate 33
Material Separation 33
No Pacing 32
Material Fragmentation 31
Material Split, Cut or Torn 29

Yearly Trend

92
1992: 9
93
1993: 18
94
1994: 50
95
1995: 58
96
1996: 123
97
1997: 196
98
1998: 186
99
1999: 116
00
2000: 127
01
2001: 94
02
2002: 49
03
2003: 56
04
2004: 36
05
2005: 46
06
2006: 46
07
2007: 168
08
2008: 400
09
2009: 145
10
2010: 147
11
2011: 249
12
2012: 221
13
2013: 149
14
2014: 178
15
2015: 163
16
2016: 154
17
2017: 115
18
2018: 133
19
2019: 144
20
2020: 104
21
2021: 97
22
2022: 130
23
2023: 229
24
2024: 226
25
2025: 268
26
2026: 52

Related Entities for Catheter, Flow Directed

Top Manufacturers

EDWARDS LIFESCIENCES, PR 1,236
EDWARDS LIFESCIENCES PR 438
EDWARDS LIFESCIENCES 352
ARROW INTERNATIONAL LLC 200
ARROW INTL., INC. 199
EV3 NEUROVASCULAR 192
ARROW INTERNATIONAL INC. 160
MEDTRONIC, INC. 157
EDWARDS LIFESCIENCES LLC 148
ABBOTT LABORATORIES 125

Event Locations

1,999 (42.7%)
HOSPITAL 1,742 (37.2%)
I 733 (15.7%)
INVALID DATA 149 (3.2%)
NO INFORMATION 28 (0.6%)
UNKNOWN 14 (0.3%)
OTHER 7 (0.1%)
NOT APPLICABLE 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
HOME 1 (0.0%)
OPERATING ROOM 1 (0.0%)
PATIENT'S HOME 1 (0.0%)

Compare EDWARDS LIFESCIENCES, PR vs EDWARDS LIFESCIENCES PR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Flow Directed, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (4,682 here).

Lavage, Jet 4,670 Ventilator, Emergency, Powered 4,700 Table, Obstetrical, Ac-Powered 4,662 Staple, Removable 4,713

Similar death-typed counts

Nearest other device types by death-typed report count (139 here), distinct from the volume row.

Catheter 138 Catheter, Subclavian 140 Microspheres Radionuclide 140 Catheter, Embolectomy 142

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.