2026 data FDA MAUDE openFDA FDA Class II

Catheter, Subclavian

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, Subclavian LIGHT-BOOK · MAUDE

#477 of 1000 · 2,170 reports · 1992–2026

  • BOOK 2,170 reports
  • RANK #477 of 1000
  • DEATH 140 death-typed
  • INJ 667 injury-typed
  • MALF 1,259 malfunction
  • SPAN 1992–2026
  • PEAK 2000: 297
  • PHOTO Pin

Nearest event-volume peer: Pin, Fixation, Threaded (2 report gap)

Catheter, Subclavian sits #477 of 1000 among tracked device types with 2,170 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 sit below the device-type norm

Catheter, Subclavian carries 58.0% MALFUNCTION-coded reports, 6.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 6.5% corpus 1.5% · above corpus mean (+4.9 pp)
  • INJ 30.7% corpus 30.3% · near corpus mean (+0.4 pp)
  • MALF 58.0% corpus 64.8% · below corpus mean (-6.8 pp)

Lead product-problem code Crack is 15% of coded problems · Lead manufacturer BARD ACCESS SYSTEMS accounts for 54% of manufacturer-tagged reports · Top event location HOSPITAL is 40% of location-tagged rows .

Catheter, Subclavian in the event-volume neighbourhood

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

reports

What this shows Catheter, Subclavian carries 2,170 MAUDE reports, ranked #477 of 1000.

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

Event Types

Malfunction 1,259 (58.0%)
Injury 667 (30.7%)
Death 140 (6.5%)
Other 64 (2.9%)
40 (1.8%)

Patient Outcomes

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

Required Intervention 810 (35.0%)
793 (34.3%)
Other 286 (12.4%)
Death 119 (5.1%)
R 102 (4.4%)
Hospitalization 91 (3.9%)
Life Threatening 63 (2.7%)
L 20 (0.9%)
O 15 (0.6%)
H 5 (0.2%)
Invalid Data 5 (0.2%)
Disability 4 (0.2%)
S 2 (0.1%)

Top Product Problems

Crack 404
Explanted 367
Break 293
Replace 242
Leak/Splash 215
Implant, removal of 183
Material Separation 102
Tears, rips, holes in device, device material 94
Fluid/Blood Leak 91
Difficult to Remove 88
Hole In Material 78
Component(s), broken 76
Unraveled Material 72
Detachment Of Device Component 68
Difficult to Insert 68
Repair 62
Fracture 60
Migration or Expulsion of Device 58
Device, removal of (non-implant) 54
Device remains implanted 48

Yearly Trend

92
1992: 11
93
1993: 8
94
1994: 37
95
1995: 30
96
1996: 70
97
1997: 155
98
1998: 181
99
1999: 139
00
2000: 297
01
2001: 241
02
2002: 122
03
2003: 74
04
2004: 49
05
2005: 54
06
2006: 57
07
2007: 27
08
2008: 22
09
2009: 26
10
2010: 45
11
2011: 23
12
2012: 34
13
2013: 29
14
2014: 23
15
2015: 26
16
2016: 34
17
2017: 31
18
2018: 31
19
2019: 45
20
2020: 43
21
2021: 37
22
2022: 34
23
2023: 44
24
2024: 48
25
2025: 28
26
2026: 15

Reports fell to 28 in 2025, down from an average of 46 in the two years before.

Related Entities for Catheter, Subclavian

Event Locations

HOSPITAL 864 (39.8%)
747 (34.4%)
I 168 (7.7%)
UNKNOWN 131 (6.0%)
OUTPATIENT TREATMENT FACILITY 97 (4.5%)
HOME 49 (2.3%)
INVALID DATA 40 (1.8%)
OTHER 39 (1.8%)
DIALYSIS CENTER 14 (0.6%)
OUTPATIENT DIAGNOSTIC FACILITY 8 (0.4%)
NO INFORMATION 5 (0.2%)
NURSING HOME 5 (0.2%)
AMBULATORY SURGICAL FACILITY 3 (0.1%)

Compare BARD ACCESS SYSTEMS vs ARROW INTERNATIONAL LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Subclavian: 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 (2,170 here).

Similar death-typed counts

Nearest other device types by death-typed report count (140 here), distinct from the volume row.

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