2026 data FDA MAUDE openFDA FDA Class II

Catheter, Conduction, Anesthetic

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 §868.5120 (Anesthesiology panel).

FDA MAUDE casebook

openFDA event book Catheter, Conduction, Anesthetic LIGHT-BOOK · MAUDE

#443 of 1000 · 2,605 reports · 1992–2026

  • BOOK 2,605 reports
  • RANK #443 of 1000
  • DEATH 9 death-typed
  • INJ 479 injury-typed
  • MALF 1,930 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 779
  • PHOTO Catheter, Urethral

Nearest event-volume peer: Catheter, Urethral (4 report gap)

Catheter, Conduction, Anesthetic sits #443 of 1000 among tracked device types with 2,605 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 →

Injury-coded reports sit below the device-type norm

Catheter, Conduction, Anesthetic carries 18.4% INJURY-coded reports, 11.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 18.4% corpus 30.3% · below corpus mean (-11.9 pp)
  • MALF 74.1% corpus 64.8% · above corpus mean (+9.3 pp)

Lead product-problem code Break is 41% of coded problems · Lead manufacturer ARROW INTERNATIONAL INC. accounts for 59% of manufacturer-tagged reports · Top event location I is 46% of location-tagged rows .

Catheter, Conduction, Anesthetic in the event-volume neighbourhood

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

reports

What this shows Catheter, Conduction, Anesthetic carries 2,605 MAUDE reports, ranked #443 of 1000.

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

Event Types

Malfunction 1,930 (74.1%)
Injury 479 (18.4%)
Other 176 (6.8%)
11 (0.4%)
Death 9 (0.3%)

Patient Outcomes

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

1,823 (68.8%)
Other 449 (16.9%)
Required Intervention 249 (9.4%)
Hospitalization 52 (2.0%)
R 44 (1.7%)
Death 10 (0.4%)
O 7 (0.3%)
H 5 (0.2%)
Disability 5 (0.2%)
Life Threatening 3 (0.1%)
L 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Break 1,115
Difficult to Remove 228
Material Twisted/Bent 163
Device, or device fragments remain in patient 138
Fluid/Blood Leak 116
Material Separation 113
Detachment Of Device Component 101
Obstruction of Flow 99
Tip breakage 93
Detachment of Device or Device Component 79
Difficult to Advance 70
Physical Resistance 67
Adverse Event Without Identified Device or Use Problem 58
No Flow 53
Material Fragmentation 49
Stretched 45
Failure to Advance 38
Fracture 37
Leak/Splash 35
Physical Resistance/Sticking 34

Yearly Trend

92
1992: 1
93
1993: 1
94
1994: 17
95
1995: 12
96
1996: 26
97
1997: 33
98
1998: 31
99
1999: 31
00
2000: 16
01
2001: 32
02
2002: 26
03
2003: 19
04
2004: 24
05
2005: 22
06
2006: 51
07
2007: 18
08
2008: 14
09
2009: 71
10
2010: 57
11
2011: 31
12
2012: 52
13
2013: 73
14
2014: 45
15
2015: 43
16
2016: 71
17
2017: 38
18
2018: 80
19
2019: 779
20
2020: 159
21
2021: 146
22
2022: 135
23
2023: 79
24
2024: 98
25
2025: 140
26
2026: 134

Reports rose to 140 in 2025, up from an average of 89 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Catheter, Conduction, Anesthetic

Event Locations

I 1,197 (46.0%)
1,024 (39.3%)
HOSPITAL 266 (10.2%)
UNKNOWN 38 (1.5%)
NO INFORMATION 27 (1.0%)
INVALID DATA 19 (0.7%)
OTHER 14 (0.5%)
AMBULATORY SURGICAL FACILITY 8 (0.3%)
OUTPATIENT TREATMENT FACILITY 6 (0.2%)
HOME 5 (0.2%)
NURSING HOME 1 (0.0%)

Compare ARROW INTERNATIONAL INC. vs ARROW INTERNATIONAL LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter, Conduction, Anesthetic: 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 (2,605 here).

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Disclaimer: MAUDE figures for Catheter, Conduction, Anesthetic 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, Conduction, Anesthetic; 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.