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2026 data FDA MAUDE openFDA FDA Class II

Catheter And Tip, Suction

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 §880.6740 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Catheter And Tip, Suction LIGHT-BOOK · MAUDE

#425 of 1000 · 2,781 reports · 1994–2026

  • BOOK 2,781 reports
  • RANK #425 of 1000
  • DEATH 16 death-typed
  • INJ 305 injury-typed
  • MALF 2,405 malfunction
  • SPAN 1994–2026
  • PEAK 2019: 442
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Thyroid-Stimulating Hormone (10 report gap)

Catheter And Tip, Suction sits #425 of 1000 among tracked device types with 2,781 MAUDE reports spanning 1994–2026. 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 run above the device-type norm

Catheter And Tip, Suction carries 86.5% MALFUNCTION-coded reports, 21.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-0.9 pp)
  • INJ 11.0% corpus 30.3% · below corpus mean (-19.3 pp)
  • MALF 86.5% corpus 64.8% · above corpus mean (+21.7 pp)

Lead product-problem code Obstruction of Flow is 27% of coded problems · Lead manufacturer ETHICON INC. accounts for 67% of manufacturer-tagged reports · Top event location is 48% of location-tagged rows .

Catheter And Tip, Suction in the event-volume neighbourhood

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

reports

What this shows Catheter And Tip, Suction carries 2,781 MAUDE reports, ranked #425 of 1000.

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

Event Types

Malfunction 2,405 (86.5%)
Injury 305 (11.0%)
Other 36 (1.3%)
19 (0.7%)
Death 16 (0.6%)

Patient Outcomes

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

2,333 (82.6%)
Required Intervention 209 (7.4%)
Other 176 (6.2%)
R 28 (1.0%)
Hospitalization 28 (1.0%)
Life Threatening 15 (0.5%)
Death 14 (0.5%)
L 9 (0.3%)
H 5 (0.2%)
O 4 (0.1%)
D 1 (0.0%)
S 1 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Obstruction of Flow 677
Device Contamination with Chemical or Other Material 315
Leak/Splash 258
Suction Problem 226
Break 222
Material Separation 131
Detachment of Device or Device Component 103
Fluid/Blood Leak 78
Adverse Event Without Identified Device or Use Problem 72
Material Integrity Problem 68
Detachment Of Device Component 63
Tip breakage 56
Unraveled Material 49
Device Contaminated During Manufacture or Shipping 46
Disconnection 37
Use of Device Problem 35
Decrease in Suction 24
Material Deformation 22
Device Dislodged or Dislocated 20
Activation Problem 19

Yearly Trend

94
1994: 7
95
1995: 6
96
1996: 2
97
1997: 8
98
1998: 8
99
1999: 15
00
2000: 5
01
2001: 16
02
2002: 6
03
2003: 25
04
2004: 18
05
2005: 9
06
2006: 19
07
2007: 17
08
2008: 14
09
2009: 17
10
2010: 25
11
2011: 17
12
2012: 25
13
2013: 34
14
2014: 42
15
2015: 27
16
2016: 61
17
2017: 181
18
2018: 161
19
2019: 442
20
2020: 187
21
2021: 283
22
2022: 221
23
2023: 197
24
2024: 277
25
2025: 279
26
2026: 130

Reports in 2025 (279) held close to the prior two-year average of 237.

Related Entities for Catheter And Tip, Suction

Top Manufacturers

ETHICON INC. 1,181
COOK INC 281
COVIDIEN 101
ARROW INTERNATIONAL INC. 92
CARDINAL HEALTH 67
ARROW INTL., INC. 29

Event Locations

1,333 (47.9%)
I 1,116 (40.1%)
HOSPITAL 278 (10.0%)
NO INFORMATION 33 (1.2%)
HOME 5 (0.2%)
INVALID DATA 4 (0.1%)
OTHER 4 (0.1%)
UNKNOWN 4 (0.1%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare ETHICON INC. vs COOK INC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Catheter And Tip, Suction: 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 (2,781 here).

Radioimmunoassay 2,771 Separator 2,769 Prosthesis, Penile 2,754 Real Time Nucleic Acid Amplification System 2,746

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Computer 16 Dilator, Esophageal 16 Implanted Subcortical Electrical Stimulator 16 Stent 16

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Catheter And Tip, Suction 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 And Tip, Suction; 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.