2026 data FDA MAUDE openFDA FDA Class II

Injector And Syringe, Angiographic

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 §870.1650 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Injector And Syringe, Angiographic LIGHT-BOOK · MAUDE

#380 of 1000 · 3,315 reports · 1992–2026

  • BOOK 3,315 reports
  • RANK #380 of 1000
  • DEATH 146 death-typed
  • INJ 1,057 injury-typed
  • MALF 1,791 malfunction
  • SPAN 1992–2026
  • PEAK 2009: 188
  • PHOTO Scaler, Ultrasonic

Nearest event-volume peer: Scaler, Ultrasonic (34 report gap)

Injector And Syringe, Angiographic sits #380 of 1000 among tracked device types with 3,315 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

Injector And Syringe, Angiographic carries 54.0% MALFUNCTION-coded reports, 10.8pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 4.4% corpus 1.5% · above corpus mean (+2.9 pp)
  • INJ 31.9% corpus 30.3% · above corpus mean (+1.6 pp)
  • MALF 54.0% corpus 64.8% · below corpus mean (-10.8 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer COVIDIEN accounts for 59% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Injector And Syringe, Angiographic in the event-volume neighbourhood

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

reports

What this shows Injector And Syringe, Angiographic carries 3,315 MAUDE reports, ranked #380 of 1000.

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

Event Types

Malfunction 1,791 (54.0%)
Injury 1,057 (31.9%)
Other 280 (8.4%)
Death 146 (4.4%)
41 (1.2%)

Patient Outcomes

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

1,694 (45.8%)
Other 621 (16.8%)
Required Intervention 375 (10.1%)
Hospitalization 297 (8.0%)
Life Threatening 179 (4.8%)
R 164 (4.4%)
Death 142 (3.8%)
L 120 (3.2%)
H 47 (1.3%)
O 37 (1.0%)
S 8 (0.2%)
Disability 8 (0.2%)
D 3 (0.1%)
Invalid Data 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 392
Air Leak 312
Unknown (for use when the device problem is not known) 230
Insufficient Device Problem Information 198
Break 182
Detachment Of Device Component 149
Device Contamination with Chemical or Other Material 148
Device Operates Differently Than Expected 117
Component Falling 114
Fluid/Blood Leak 100
Improper or Incorrect Procedure or Method 98
Use of Device Problem 95
Bubble(s) 83
Self-Activation or Keying 70
Crack 67
Component(s), broken 65
Manufacturing, Packaging or Shipping Problem 55
Loose or Intermittent Connection 54
Device Displays Incorrect Message 49
Replace 49

Yearly Trend

92
1992: 4
93
1993: 1
94
1994: 2
96
1996: 15
97
1997: 73
98
1998: 83
99
1999: 69
00
2000: 54
01
2001: 41
02
2002: 85
03
2003: 81
04
2004: 100
05
2005: 101
06
2006: 77
07
2007: 107
08
2008: 168
09
2009: 188
10
2010: 124
11
2011: 133
12
2012: 135
13
2013: 141
14
2014: 97
15
2015: 135
16
2016: 152
17
2017: 128
18
2018: 129
19
2019: 121
20
2020: 93
21
2021: 132
22
2022: 111
23
2023: 117
24
2024: 118
25
2025: 97
26
2026: 103

Reports in 2025 (97) held close to the prior two-year average of 118.

Related Entities for Injector And Syringe, Angiographic

Top Manufacturers

Event Locations

1,898 (57.3%)
I 692 (20.9%)
HOSPITAL 420 (12.7%)
NOT APPLICABLE 198 (6.0%)
NO INFORMATION 40 (1.2%)
OTHER 24 (0.7%)
INVALID DATA 17 (0.5%)
OUTPATIENT DIAGNOSTIC FACILITY 10 (0.3%)
UNKNOWN 9 (0.3%)
OUTPATIENT TREATMENT FACILITY 6 (0.2%)
CATHETERIZATION LAB - FREE STANDING 1 (0.0%)

Compare COVIDIEN vs B. BRAUN MEDICAL INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Injector And Syringe, Angiographic: 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 (3,315 here).

Similar death-typed counts

Nearest other device types by death-typed report count (146 here), distinct from the volume row.

Disclaimer: MAUDE figures for Injector And Syringe, Angiographic 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 Injector And Syringe, Angiographic; 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.