2026 data FDA MAUDE openFDA FDA Class II

Catheter, Coude

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 §876.5130 (Gastroenterology, Urology panel).

FDA MAUDE casebook

openFDA event book Catheter, Coude MID-BOOK · MAUDE

#215 of 1000 · 10,370 reports · 1998–2026

  • BOOK 10,370 reports
  • RANK #215 of 1000
  • DEATH 1 death-typed
  • INJ 1,090 injury-typed
  • MALF 9,276 malfunction
  • SPAN 1998–2026
  • PEAK 2022: 1,365
  • PHOTO Plate, Bone

Nearest event-volume peer: Plate, Bone (23 report gap)

Catheter, Coude sits #215 of 1000 among tracked device types with 10,370 MAUDE reports spanning 1998–2026. 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, Coude carries 89.5% MALFUNCTION-coded reports, 24.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 10.5% corpus 30.3% · below corpus mean (-19.8 pp)
  • MALF 89.5% corpus 64.8% · above corpus mean (+24.6 pp)

Lead product-problem code Deflation Problem is 13% of coded problems · Lead manufacturer C.R. BARD, INC. (COVINGTON) -1018233 accounts for 83% of manufacturer-tagged reports · Top event location is 54% of location-tagged rows .

Catheter, Coude in the event-volume neighbourhood

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

reports

What this shows Catheter, Coude carries 10,370 MAUDE reports, ranked #215 of 1000.

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

Event Types

Malfunction 9,276 (89.5%)
Injury 1,090 (10.5%)
Other 2 (0.0%)
Death 1 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

Other 6,193 (59.2%)
3,521 (33.6%)
Required Intervention 580 (5.5%)
R 93 (0.9%)
Hospitalization 35 (0.3%)
O 32 (0.3%)
H 3 (0.0%)
Life Threatening 3 (0.0%)
L 2 (0.0%)
Disability 2 (0.0%)
D 1 (0.0%)
S 1 (0.0%)
Death 1 (0.0%)

Top Product Problems

Deflation Problem 1,307
Fluid/Blood Leak 993
Burst Container or Vessel 979
Material Puncture/Hole 919
Difficult to Remove 910
Material Rupture 743
Decrease in Pressure 498
Inflation Problem 491
Failure to Infuse 466
Partial Blockage 398
Inaccurate Flow Rate 387
Break 337
Leak/Splash 318
Material Fragmentation 298
Device Dislodged or Dislocated 244
Erratic or Intermittent Display 221
Adverse Event Without Identified Device or Use Problem 211
Material Split, Cut or Torn 188
Disconnection 155
Device Fell 154

Yearly Trend

98
1998: 1
12
2012: 1
13
2013: 3
14
2014: 14
15
2015: 20
16
2016: 170
17
2017: 963
18
2018: 886
19
2019: 1,000
20
2020: 1,027
21
2021: 1,030
22
2022: 1,365
23
2023: 1,142
24
2024: 957
25
2025: 1,231
26
2026: 560

Reports in 2025 (1,231) held close to the prior two-year average of 1,050.

Related Entities for Catheter, Coude

Event Locations

5,562 (53.6%)
I 4,662 (45.0%)
HOSPITAL 113 (1.1%)
NO INFORMATION 19 (0.2%)
OTHER 8 (0.1%)
HOME 4 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)

Compare C.R. BARD, INC. (COVINGTON) -1018233 vs C.R. BARD INC. (COVINGTON) -1018233 →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Coude: 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 (10,370 here).

Similar death-typed counts

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

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