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2026 data FDA MAUDE openFDA FDA Class II

Catheter, Continuous Flush

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 §870.1210 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Catheter, Continuous Flush LIGHT-BOOK · MAUDE

#231 of 1000 · 8,965 reports · 1992–2026

  • BOOK 8,965 reports
  • RANK #231 of 1000
  • DEATH 358 death-typed
  • INJ 1,877 injury-typed
  • MALF 6,655 malfunction
  • SPAN 1992–2026
  • PEAK 2025: 991
  • PHOTO Percutaneous Cardiac…

Nearest event-volume peer: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (16 report gap)

Catheter, Continuous Flush sits #231 of 1000 among tracked device types with 8,965 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 →

Malfunction reports run above the device-type norm

Catheter, Continuous Flush carries 74.2% MALFUNCTION-coded reports, 9.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.0% corpus 1.5% · above corpus mean (+2.5 pp)
  • INJ 20.9% corpus 30.3% · below corpus mean (-9.4 pp)
  • MALF 74.2% corpus 64.8% · above corpus mean (+9.4 pp)

Lead product-problem code Physical Resistance/Sticking is 17% of coded problems · Lead manufacturer MICRO THERAPEUTICS, INC. DBA EV3 accounts for 34% of manufacturer-tagged reports · Top event location is 63% of location-tagged rows .

Catheter, Continuous Flush in the event-volume neighbourhood

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

reports

What this shows Catheter, Continuous Flush carries 8,965 MAUDE reports, ranked #231 of 1000.

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

Event Types

Malfunction 6,655 (74.2%)
Injury 1,877 (20.9%)
Death 358 (4.0%)
44 (0.5%)
Other 31 (0.3%)

Patient Outcomes

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

6,426 (68.5%)
Required Intervention 869 (9.3%)
Other 773 (8.2%)
Death 323 (3.4%)
Disability 219 (2.3%)
R 168 (1.8%)
Life Threatening 163 (1.7%)
Hospitalization 141 (1.5%)
S 79 (0.8%)
L 78 (0.8%)
H 60 (0.6%)
O 54 (0.6%)
D 31 (0.3%)

Top Product Problems

Physical Resistance/Sticking 1,503
Break 1,488
Adverse Event Without Identified Device or Use Problem 1,281
Leak/Splash 468
Material Separation 356
Material Deformation 354
Fracture 332
Difficult to Remove 314
Detachment of Device or Device Component 289
Physical Resistance 285
Obstruction of Flow 272
Burst Container or Vessel 261
Material Rupture 250
Entrapment of Device 206
Detachment Of Device Component 192
Difficult to Advance 171
Device Dislodged or Dislocated 166
Fluid/Blood Leak 157
Device Damaged by Another Device 156
Material Integrity Problem 149

Yearly Trend

92
1992: 1
93
1993: 1
96
1996: 1
97
1997: 1
98
1998: 8
99
1999: 22
00
2000: 22
01
2001: 31
02
2002: 33
03
2003: 49
04
2004: 52
05
2005: 109
06
2006: 134
07
2007: 118
08
2008: 117
09
2009: 187
10
2010: 356
11
2011: 239
12
2012: 217
13
2013: 209
14
2014: 276
15
2015: 339
16
2016: 418
17
2017: 538
18
2018: 434
19
2019: 418
20
2020: 381
21
2021: 440
22
2022: 543
23
2023: 829
24
2024: 940
25
2025: 991
26
2026: 511

Reports in 2025 (991) held close to the prior two-year average of 885.

Related Entities for Catheter, Continuous Flush

Top Manufacturers

MICRO THERAPEUTICS, INC. DBA EV3 1,796
BOSTON SCIENTIFIC CORPORATION 1,105
MEDOS INTERNATIONAL SARL 666
COOK INC 508
BOSTON SCIENTIFIC - CORK 481
COVIDIEN 374
EV3 NEUROVASCULAR 305

Event Locations

5,690 (63.5%)
I 2,579 (28.8%)
HOSPITAL 648 (7.2%)
NO INFORMATION 33 (0.4%)
OUTPATIENT TREATMENT FACILITY 7 (0.1%)
OTHER 4 (0.0%)
INVALID DATA 3 (0.0%)
UNKNOWN 1 (0.0%)

Compare MICRO THERAPEUTICS, INC. DBA EV3 vs BOSTON SCIENTIFIC CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Continuous Flush: 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 (8,965 here).

Percutaneous Cardiac Ablation Catheter For… 8,981 Negative Pressure Wound Therapy Powered Suc… 9,164 Controller 9,165 Catheter 8,756

Similar death-typed counts

Nearest other device types by death-typed report count (358 here), distinct from the volume row.

Stents 359 Oximeter 360 Artificial Heart 368 Catheter 347

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Catheter, Continuous Flush 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, Continuous Flush; 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.