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2026 data FDA MAUDE openFDA FDA Class I

Catheter, Irrigation

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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §878.4200 (General, Plastic Surgery panel).

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FDA MAUDE casebook

openFDA event book Catheter, Irrigation LIGHT-BOOK · MAUDE

#297 of 1000 · 5,798 reports · 1993–2026

  • BOOK 5,798 reports
  • RANK #297 of 1000
  • DEATH 26 death-typed
  • INJ 1,035 injury-typed
  • MALF 4,721 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 1,193
  • PHOTO Extended Depth Of Foc…

Nearest event-volume peer: Extended Depth Of Focus Intraocular Lens (18 report gap)

Catheter, Irrigation sits #297 of 1000 among tracked device types with 5,798 MAUDE reports spanning 1993–2026. 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, Irrigation carries 81.4% MALFUNCTION-coded reports, 16.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.4% corpus 1.5% · below corpus mean (-1.1 pp)
  • INJ 17.9% corpus 30.3% · below corpus mean (-12.4 pp)
  • MALF 81.4% corpus 64.8% · above corpus mean (+16.6 pp)

Lead product-problem code Fracture is 24% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 54% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .

Catheter, Irrigation in the event-volume neighbourhood

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

reports

What this shows Catheter, Irrigation carries 5,798 MAUDE reports, ranked #297 of 1000.

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

Event Types

Malfunction 4,721 (81.4%)
Injury 1,035 (17.9%)
Death 26 (0.4%)
Other 13 (0.2%)
3 (0.1%)

Patient Outcomes

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

4,125 (69.6%)
Required Intervention 852 (14.4%)
Other 669 (11.3%)
R 104 (1.8%)
Hospitalization 80 (1.3%)
Death 25 (0.4%)
O 21 (0.4%)
Life Threatening 20 (0.3%)
L 13 (0.2%)
H 12 (0.2%)
Disability 5 (0.1%)
D 1 (0.0%)
S 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Fracture 1,488
Break 1,089
Material Separation 724
Fluid/Blood Leak 537
Defective Component 375
Nonstandard Device 239
Material Integrity Problem 238
Leak/Splash 219
Adverse Event Without Identified Device or Use Problem 182
Material Fragmentation 121
Infusion or Flow Problem 119
Device Contamination with Chemical or Other Material 111
Device Contaminated During Manufacture or Shipping 110
Difficult to Remove 106
Crack 99
Dull, Blunt 80
Detachment Of Device Component 75
Suction Problem 66
Disconnection 63
Replace 62

Yearly Trend

93
1993: 1
94
1994: 1
96
1996: 4
97
1997: 4
98
1998: 4
99
1999: 9
00
2000: 8
01
2001: 8
02
2002: 64
03
2003: 17
04
2004: 30
05
2005: 25
06
2006: 19
07
2007: 11
08
2008: 16
09
2009: 24
10
2010: 35
11
2011: 40
12
2012: 46
13
2013: 49
14
2014: 51
15
2015: 58
16
2016: 86
17
2017: 176
18
2018: 277
19
2019: 196
20
2020: 198
21
2021: 383
22
2022: 477
23
2023: 628
24
2024: 945
25
2025: 1,193
26
2026: 715

Reports rose to 1,193 in 2025, up from an average of 787 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Irrigation

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 2,480
ETHICON INC. 966
C.R. BARD, INC. (COVINGTON) -1018233 452
COOK INC 290
C.R. BARD INC. (COVINGTON) -1018233 179
BARD ACCESS SYSTEMS 133
MERIT MEDICAL SYSTEMS, INC. 106

Event Locations

4,275 (73.7%)
I 1,063 (18.3%)
HOSPITAL 382 (6.6%)
NO INFORMATION 47 (0.8%)
OTHER 19 (0.3%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
HOME 4 (0.1%)
INVALID DATA 2 (0.0%)
OPERATING ROOM 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs ETHICON INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Irrigation: 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 (5,798 here).

Extended Depth Of Focus Intraocular Lens 5,816 Holder, Head, Neurosurgical 5,826 Stent, Ureteral 5,858 Ultrasound Bronchoscope 5,860

Similar death-typed counts

Nearest other device types by death-typed report count (26 here), distinct from the volume row.

Catheter 26 Pump 26 Agent 27 Aid, Transfer 25

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

Disclaimer: MAUDE figures for Catheter, Irrigation 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, Irrigation; 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.