2026 data FDA MAUDE openFDA FDA Class II

Cannula, Catheter

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 §870.1300 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Cannula, Catheter LIGHT-BOOK · MAUDE

#800 of 1000 · 654 reports · 1992–2026

  • BOOK 654 reports
  • RANK #800 of 1000
  • DEATH 23 death-typed
  • INJ 208 injury-typed
  • MALF 395 malfunction
  • SPAN 1992–2026
  • PEAK 1997: 80
  • PHOTO Instrument For Treatm…

Nearest event-volume peer: Instrument For Treatment Of Hyperhidrosis (1 report gap)

Cannula, Catheter sits #800 of 1000 among tracked device types with 654 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

Cannula, Catheter carries 60.4% MALFUNCTION-coded reports, 4.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.5% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 31.8% corpus 30.3% · above corpus mean (+1.5 pp)
  • MALF 60.4% corpus 64.8% · below corpus mean (-4.4 pp)

Lead product-problem code Break is 16% of coded problems · Lead manufacturer B. BRAUN MELSUNGEN AG accounts for 53% of manufacturer-tagged reports · Top event location HOSPITAL is 59% of location-tagged rows .

Cannula, Catheter in the event-volume neighbourhood

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

reports

What this shows Cannula, Catheter carries 654 MAUDE reports, ranked #800 of 1000.

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

Event Types

Malfunction 395 (60.4%)
Injury 208 (31.8%)
Death 23 (3.5%)
Other 21 (3.2%)
7 (1.1%)

Patient Outcomes

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

277 (38.6%)
Other 193 (26.9%)
Required Intervention 123 (17.2%)
R 36 (5.0%)
Hospitalization 26 (3.6%)
Death 21 (2.9%)
L 18 (2.5%)
Life Threatening 10 (1.4%)
H 4 (0.6%)
O 3 (0.4%)
Disability 3 (0.4%)
Invalid Data 2 (0.3%)
S 1 (0.1%)

Top Product Problems

Break 77
Material Separation 55
Activation, Positioning or Separation Problem 43
Other (for use when an appropriate device code cannot be identified) 35
Positioning Failure 28
Replace 28
Leak/Splash 26
Fluid/Blood Leak 25
Adverse Event Without Identified Device or Use Problem 23
Balloon leak(s) 21
Inflation Problem 20
Difficult to Remove 18
Insufficient Device Problem Information 16
Fracture 14
Balloon burst 12
Detachment Of Device Component 12
Device Issue 12
Tears, rips, holes in device, device material 11
Detachment of Device or Device Component 10
Hole In Material 10

Yearly Trend

92
1992: 6
94
1994: 5
95
1995: 3
96
1996: 22
97
1997: 80
98
1998: 31
99
1999: 18
00
2000: 25
01
2001: 31
02
2002: 20
03
2003: 3
04
2004: 8
05
2005: 11
06
2006: 17
07
2007: 17
08
2008: 8
09
2009: 27
10
2010: 24
11
2011: 7
12
2012: 7
13
2013: 6
14
2014: 8
15
2015: 40
16
2016: 75
17
2017: 29
18
2018: 16
19
2019: 16
20
2020: 4
21
2021: 11
22
2022: 27
23
2023: 36
24
2024: 7
25
2025: 6
26
2026: 3

Reports fell to 6 in 2025, down from an average of 22 in the two years before.

Related Entities for Cannula, Catheter

Event Locations

HOSPITAL 388 (59.3%)
185 (28.3%)
I 46 (7.0%)
INVALID DATA 13 (2.0%)
OTHER 10 (1.5%)
NO INFORMATION 8 (1.2%)
HOME 2 (0.3%)
UNKNOWN 2 (0.3%)

Compare B. BRAUN MELSUNGEN AG vs COOK, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Cannula, Catheter: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

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