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2026 data FDA MAUDE openFDA FDA Class II

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

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 §876.5010 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Biliary Catheter For Stone Removal That May… LIGHT-BOOK · MAUDE

#934 of 1000 · 441 reports · 1992–2026

  • BOOK 441 reports
  • RANK #934 of 1000
  • DEATH 1 death-typed
  • INJ 79 injury-typed
  • MALF 359 malfunction
  • SPAN 1992–2026
  • PEAK 2017: 85
  • PHOTO Inhibitor

Nearest event-volume peer: Inhibitor, Peridural Fibrosis (Adhesion Barrier) (1 report gap)

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection sits #934 of 1000 among tracked device types with 441 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

Biliary Catheter For Stone Removal That May… 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 0.2% corpus 1.5% · below corpus mean (-1.3 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 Deflation Problem is 14% of coded problems · Lead manufacturer COOK INC accounts for 40% of manufacturer-tagged reports · Top event location is 43% of location-tagged rows .

Biliary Catheter For Stone Removal That May… in the event-volume neighbourhood

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

reports

What this shows Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection carries 441 MAUDE reports, ranked #934 of 1000.

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

Event Types

Malfunction 359 (81.4%)
Injury 79 (17.9%)
2 (0.5%)
Death 1 (0.2%)

Patient Outcomes

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

357 (81.0%)
Required Intervention 70 (15.9%)
Other 7 (1.6%)
R 3 (0.7%)
Hospitalization 2 (0.5%)
H 1 (0.2%)
Death 1 (0.2%)

Top Product Problems

Deflation Problem 61
Material Rupture 44
Difficult to Remove 42
Leak/Splash 36
Break 32
Material Separation 30
Burst Container or Vessel 20
Detachment Of Device Component 20
Balloon burst 19
Inflation Problem 19
Balloon rupture 18
Material Protrusion/Extrusion 18
Adverse Event Without Identified Device or Use Problem 14
Material Fragmentation 11
Fluid/Blood Leak 10
Improper or Incorrect Procedure or Method 10
Difficult to Advance 9
Component Falling 6
Detachment of Device or Device Component 6
Fracture 5

Yearly Trend

92
1992: 1
95
1995: 1
96
1996: 1
97
1997: 1
01
2001: 1
03
2003: 4
05
2005: 1
06
2006: 1
07
2007: 6
08
2008: 36
09
2009: 34
10
2010: 12
11
2011: 10
12
2012: 9
13
2013: 10
14
2014: 11
15
2015: 20
16
2016: 14
17
2017: 85
18
2018: 38
19
2019: 38
20
2020: 20
21
2021: 8
22
2022: 18
23
2023: 11
24
2024: 14
25
2025: 24
26
2026: 12

Reports rose to 24 in 2025, up from an average of 13 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Top Manufacturers

COOK INC 150
WILSON-COOK MEDICAL INC 69
COOK ENDOSCOPY 68
BOSTON SCIENTIFIC 29
WILSON-COOK MEDICAL INC. 16
BOSTON SCIENTIFIC CORPORATION 14
WILSON-COOK MEDICAL, INC. 12
BOSTON SCIENTIFIC - CORK 8
TELEFLEX MEDICAL 8

Event Locations

190 (43.1%)
I 164 (37.2%)
HOSPITAL 82 (18.6%)
NO INFORMATION 3 (0.7%)
AMBULATORY SURGICAL FACILITY 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)

Compare COOK INC vs WILSON-COOK MEDICAL INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Biliary Catheter For Stone Removal That May…: 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 (441 here).

Inhibitor, Peridural Fibrosis 440 Resectoscope, Working Element 440 System, X-Ray, Mammographic 443 Lithotriptor, Electro-Hydraulic 438

Similar death-typed counts

Nearest other device types by death-typed report count (1 here), distinct from the volume row.

Abutment, Implant, Dental, Endosseous 1 Active Implantable Bone Conduction Hearing… 1 Aid, Surgical, Viscoelastic 1 Alarm, Conditioned Response Enuresis 1

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

Disclaimer: MAUDE figures for Biliary Catheter For Stone Removal That May… 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 Biliary Catheter For Stone Removal That May…; 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.