2026 data FDA MAUDE openFDA FDA Class II

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.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §876.5540 (Gastroenterology, Urology panel).

FDA MAUDE casebook

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

#200 of 1000 · 11,428 reports · 1994–2026

  • BOOK 11,428 reports
  • RANK #200 of 1000
  • DEATH 301 death-typed
  • INJ 2,289 injury-typed
  • MALF 8,663 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 1,071
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (36 report gap)

Catheter, Hemodialysis, Implanted sits #200 of 1000 among tracked device types with 11,428 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 →

Malfunction reports run above the device-type norm

Catheter, Hemodialysis, Implanted carries 75.8% MALFUNCTION-coded reports, 11.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 20.0% corpus 30.3% · below corpus mean (-10.3 pp)
  • MALF 75.8% corpus 64.8% · above corpus mean (+11.0 pp)

Lead product-problem code Break is 12% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 38% of manufacturer-tagged reports · Top event location is 54% 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 11,428 MAUDE reports, ranked #200 of 1000.

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

Event Types

Malfunction 8,663 (75.8%)
Injury 2,289 (20.0%)
Death 301 (2.6%)
Other 124 (1.1%)
50 (0.4%)
No answer provided 1 (0.0%)

Patient Outcomes

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

7,254 (61.1%)
Required Intervention 2,771 (23.3%)
Other 739 (6.2%)
R 274 (2.3%)
Death 272 (2.3%)
Hospitalization 261 (2.2%)
Life Threatening 90 (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 1,299
Fluid/Blood Leak 1,183
Crack 1,082
Leak/Splash 988
Explanted 876
Fracture 766
Deformation Due to Compressive Stress 462
Material Separation 444
Material Deformation 392
Replace 384
Defective Component 378
Material Puncture/Hole 364
Hole In Material 337
Detachment Of Device Component 334
Difficult to Remove 244
Restricted Flow rate 239
Adverse Event Without Identified Device or Use Problem 238
Detachment of Device or Device Component 234
Migration or Expulsion of Device 223
Material Opacification 183

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: 1,071
26
2026: 569

Reports rose to 1,071 in 2025, up from an average of 692 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Hemodialysis, Implanted

Event Locations

6,199 (54.2%)
I 2,885 (25.2%)
HOSPITAL 1,801 (15.8%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Hemodialysis, Implanted: 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 (11,428 here).

Similar death-typed counts

Nearest other device types by death-typed report count (301 here), distinct from the volume row.

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.