What are FDA adverse event reports for Catheter, Irrigation?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Catheter, Irrigation, there are 5,333 total reports including 26 death reports and 993 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Catheter, Irrigation?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Catheter, Irrigation

Name: Catheter, Irrigation - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Catheter, Irrigation LIGHT-BOOK · MAUDE

#300 of 1000 · 5,333 reports · 1993–2026

BOOK 5,333 reports
RANK #300 of 1000
DEATH 26 death-typed
INJ 993 injury-typed
MALF 4,298 malfunction
SPAN 1993–2026
PEAK 2025: 1,193
PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented (43 report gap)

Catheter, Irrigation sits #300 of 1000 among tracked device types with 5,333 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 →

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 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 18.6% corpus 30.4% · below corpus mean (-11.8 pp)
MALF 80.6% corpus 64.5% · above corpus mean (+16.1 pp)

Lead product-problem code Fracture is 25% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 52% of manufacturer-tagged reports · Top event location is 71% of location-tagged rows .

Suture

5,414
Prosthesis

5,391
Catheter (this)

5,333
Prosthesis

5,290
Sterilizer

5,221
System

5,150

What this shows Catheter, Irrigation carries 5,333 MAUDE reports, ranked #300 of 1000.

Event Types

Malfunction 4,298 (80.6%)

Injury 993 (18.6%)

Death 26 (0.5%)

Other 13 (0.2%)

3 (0.1%)

Patient Outcomes

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

3,733 (68.4%)

Required Intervention 821 (15.0%)

Other 631 (11.6%)

R 101 (1.8%)

Hospitalization 78 (1.4%)

Death 25 (0.5%)

O 20 (0.4%)

Life Threatening 19 (0.3%)

L 13 (0.2%)

H 11 (0.2%)

Disability 5 (0.1%)

D 1 (0.0%)

S 1 (0.0%)

Invalid Data 1 (0.0%)

Yearly Trend

1993: 1

1994: 1

1996: 4

1997: 4

1998: 4

1999: 9

2000: 8

2001: 8

2002: 64

2003: 17

2004: 30

2005: 25

2006: 19

2007: 11

2008: 16

2009: 24

2010: 35

2011: 40

2012: 46

2013: 49

2014: 51

2015: 58

2016: 86

2017: 176

2018: 277

2019: 196

2020: 198

2021: 383

2022: 477

2023: 628

2024: 945

2025: 1,193

2026: 250

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 2,180

ETHICON INC. 897

C.R. BARD, INC. (COVINGTON) -1018233 452

COOK INC 287

C.R. BARD INC. (COVINGTON) -1018233 155

BARD ACCESS SYSTEMS 133

MERIT MEDICAL SYSTEMS, INC. 98

Event Locations

3,813 (71.5%)

I 1,064 (20.0%)

HOSPITAL 378 (7.1%)

NO INFORMATION 47 (0.9%)

OTHER 19 (0.4%)

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 similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Irrigation, 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 (5,333 here).

Prosthesis 5,290 Prosthesis 5,391 Suture, Absorbable, Synthetic 5,414 Sterilizer, Chemical 5,221

Similar death-typed counts

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

Biopsy Needle 26 Catheter 26 Pump 26 Stimulator 26

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.

Catheter, Irrigation

Event-type mix vs corpus