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Catheter, Conduction, Anesthetic

Open-data reference.

FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Catheter, Conduction, Anesthetic

The FDA MAUDE database aggregates 2,498 adverse-event reports for Catheter, Conduction, Anesthetic spanning the period from 1992 through 2026. Of these, 9 are classified as death reports, 476 as injury reports, and 1,826 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Break topping the list at 839 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 35 years of MAUDE data, with the peak single-year volume reaching 779 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 11 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

2,498
Total Reports
9
Death Reports
476
Injury Reports
1,826
Malfunctions

Event Types

Malfunction 1,826 (73.1%)
Injury 476 (19.1%)
Other 176 (7.0%)
11 (0.4%)
Death 9 (0.4%)

Patient Outcomes

1,733 (67.8%)
Other 445 (17.4%)
Required Intervention 249 (9.7%)
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 839
Obstruction of Flow 95
Material Twisted/Bent 92
Fluid/Blood Leak 91
Detachment of Device or Device Component 75
Difficult to Advance 70
Material Separation 69
No Flow 50
Physical Resistance/Sticking 34
Adverse Event Without Identified Device or Use Problem 31
Device Handling Problem 28
Failure to Advance 27
Difficult to Remove 25
Material Fragmentation 24
Device Operates Differently Than Expected 22
Material Split, Cut or Torn 21
Leak/Splash 19
Fracture 18
Disconnection 16
Device Damaged by Another Device 15

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: 27

Related Entities for Catheter, Conduction, Anesthetic

Event Locations

I 1,197 (47.9%)
918 (36.7%)
HOSPITAL 265 (10.6%)
UNKNOWN 38 (1.5%)
NO INFORMATION 27 (1.1%)
INVALID DATA 19 (0.8%)
OTHER 14 (0.6%)
AMBULATORY SURGICAL FACILITY 8 (0.3%)
OUTPATIENT TREATMENT FACILITY 6 (0.2%)
HOME 5 (0.2%)
NURSING HOME 1 (0.0%)

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Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.