What are FDA adverse event reports for Catheter, Cholangiography?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Catheter, Cholangiography, there are 386 total reports including 2 death reports and 87 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, Cholangiography?

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, Cholangiography

Name: Catheter, Cholangiography - 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.

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

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Catheter, Cholangiography LIGHT-BOOK · MAUDE

#982 of 1000 · 386 reports · 1992–2026

BOOK 386 reports
RANK #982 of 1000
DEATH 2 death-typed
INJ 87 injury-typed
MALF 269 malfunction
SPAN 1992–2026
PEAK 2018: 51
PHOTO Blood Pump For Ecmo

Nearest event-volume peer: Blood Pump For Ecmo, Long-Term (> 6 Hours) Use (0 report gap)

Catheter, Cholangiography sits #982 of 1000 among tracked device types with 386 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, Cholangiography carries 22.5% INJURY-coded reports, 7.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 22.5% corpus 30.3% · below corpus mean (-7.8 pp)
MALF 69.7% corpus 64.8% · above corpus mean (+4.9 pp)

Lead product-problem code Break is 17% of coded problems · Lead manufacturer COOK INC accounts for 35% of manufacturer-tagged reports · Top event location HOSPITAL is 40% of location-tagged rows .

Reagent Red B…

389
Catheter (this)

386
Blood Pump Fo…

386
Indicator

386
Scissors

385
Refrigerator

383

What this shows Catheter, Cholangiography carries 386 MAUDE reports, ranked #982 of 1000.

Event Types

Malfunction 269 (69.7%)

Injury 87 (22.5%)

Other 22 (5.7%)

6 (1.6%)

Death 2 (0.5%)

Patient Outcomes

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

228 (57.4%)

Other 72 (18.1%)

Required Intervention 72 (18.1%)

Hospitalization 10 (2.5%)

R 7 (1.8%)

L 3 (0.8%)

Death 2 (0.5%)

O 1 (0.3%)

Invalid Data 1 (0.3%)

Life Threatening 1 (0.3%)

Yearly Trend

1992: 1

1994: 1

1995: 5

1996: 10

1997: 24

1998: 21

1999: 3

2000: 3

2001: 4

2002: 7

2003: 2

2004: 6

2005: 14

2006: 8

2007: 6

2008: 30

2009: 21

2010: 12

2011: 16

2012: 12

2013: 9

2014: 16

2015: 12

2016: 8

2017: 21

2018: 51

2019: 12

2020: 11

2021: 7

2022: 7

2023: 5

2024: 4

2025: 12

2026: 5

Reports rose to 12 in 2025, up from an average of 5 in the two years before - a recent-year increase, not a lifetime pattern.

Top Manufacturers

COOK INC 54

COOK, INC. 30

ATRIUM MEDICAL CORPORATION 28

TELEFLEX MEDICAL 23

BOSTON SCIENTIFIC 11

ARROW INTL., INC. 10

Event Locations

HOSPITAL 156 (40.4%)

122 (31.6%)

I 89 (23.1%)

NO INFORMATION 7 (1.8%)

INVALID DATA 5 (1.3%)

OTHER 3 (0.8%)

HOME 1 (0.3%)

NURSING HOME 1 (0.3%)

OUTPATIENT TREATMENT FACILITY 1 (0.3%)

UNKNOWN 1 (0.3%)

Compare COOK INC vs COOK, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Cholangiography: 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 (386 here).

Blood Pump For Ecmo, Long-Term Use 386 Indicator 386 Scissors, Ophthalmic 385 Reagent Red Blood Cells 389

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Catheter, Cholangiography 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, Cholangiography; 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, Cholangiography

Injury-coded reports sit below the device-type norm