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2026 data FDA MAUDE openFDA

Catheter, Hemodialysis, Implanted

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.

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FDA MAUDE casebook

openFDA event book Catheter, Hemodialysis, Implanted MID-BOOK · MAUDE

#200 of 1000 · 11,029 reports · 1994–2026

  • BOOK 11,029 reports
  • RANK #200 of 1000
  • DEATH 297 death-typed
  • INJ 2,221 injury-typed
  • MALF 8,336 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,068
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (60 report gap)

Catheter, Hemodialysis, Implanted sits #200 of 1000 among tracked device types with 11,029 MAUDE reports spanning 1994–2026. 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 2.7% corpus 1.5% · above corpus mean (+1.2 pp)
  • INJ 20.1% corpus 30.4% · below corpus mean (-10.3 pp)
  • MALF 75.6% corpus 64.5% · above corpus mean (+11.1 pp)

Lead product-problem code Break is 15% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 32% of manufacturer-tagged reports · Top event location is 53% of location-tagged rows .

Catheter, Hemodialysis, Implanted in the event-volume neighbourhood

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

reports

What this shows Catheter, Hemodialysis, Implanted carries 11,029 MAUDE reports, ranked #200 of 1000.

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

Event Types

Malfunction 8,336 (75.6%)
Injury 2,221 (20.1%)
Death 297 (2.7%)
Other 124 (1.1%)
50 (0.5%)
No answer provided 1 (0.0%)

Patient Outcomes

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

6,948 (60.5%)
Required Intervention 2,691 (23.4%)
Other 738 (6.4%)
R 273 (2.4%)
Death 268 (2.3%)
Hospitalization 261 (2.3%)
Life Threatening 89 (0.8%)
O 58 (0.5%)
H 54 (0.5%)
L 51 (0.4%)
Disability 26 (0.2%)
D 11 (0.1%)
S 9 (0.1%)

Top Product Problems

Break 919
Fluid/Blood Leak 730
Fracture 613
Deformation Due to Compressive Stress 427
Crack 365
Defective Component 358
Material Puncture/Hole 350
Material Deformation 309
Leak/Splash 283
Detachment of Device or Device Component 208
Adverse Event Without Identified Device or Use Problem 195
Material Separation 187
Restricted Flow rate 184
Material Opacification 175
Stretched 160
Obstruction of Flow 150
Material Integrity Problem 145
Difficult to Remove 141
Insufficient Flow or Under Infusion 137
Air/Gas in Device 115

Yearly Trend

94
1994: 2
96
1996: 2
97
1997: 31
98
1998: 32
99
1999: 82
00
2000: 173
01
2001: 293
02
2002: 461
03
2003: 255
04
2004: 299
05
2005: 178
06
2006: 114
07
2007: 118
08
2008: 174
09
2009: 173
10
2010: 306
11
2011: 268
12
2012: 367
13
2013: 363
14
2014: 506
15
2015: 550
16
2016: 532
17
2017: 484
18
2018: 463
19
2019: 645
20
2020: 401
21
2021: 523
22
2022: 610
23
2023: 542
24
2024: 841
25
2025: 1,068
26
2026: 173

Related Entities for Catheter, Hemodialysis, Implanted

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 1,713
COVIDIEN 1,411
BARD ACCESS SYSTEMS 1,118
ARROW INTERNATIONAL LLC 435
ARROW INTERNATIONAL INC. 346
ANGIODYNAMICS 276

Event Locations

5,802 (52.6%)
I 2,885 (26.2%)
HOSPITAL 1,799 (16.3%)
NOT APPLICABLE 166 (1.5%)
OUTPATIENT TREATMENT FACILITY 132 (1.2%)
OTHER 68 (0.6%)
UNKNOWN 54 (0.5%)
NO INFORMATION 48 (0.4%)
HOME 29 (0.3%)
INVALID DATA 20 (0.2%)
DIALYSIS CENTER 15 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 7 (0.1%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
DIALYSIS UNIT 1 (0.0%)
NURSING HOME 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Catheter, Hemodialysis, Implanted, 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 (11,029 here).

Catheter 10,969 Image-Intensified Fluoroscopic X-Ray System 10,959 Intracranial Aneurysm Flow Diverter 11,101 Dermal Cooling Pack/Vacuum/Massager 11,111

Similar death-typed counts

Nearest other device types by death-typed report count (297 here), distinct from the volume row.

Catheter 300 Acid, Hyaluronic, Intraarticular 301 Port & Catheter 293 Catheter 288

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

Disclaimer: MAUDE figures for Catheter, Hemodialysis, Implanted 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, Hemodialysis, Implanted; 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.