2026 data FDA MAUDE openFDA FDA Class II

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

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 §870.4290 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Adaptor LIGHT-BOOK · MAUDE

#480 of 1000 · 2,152 reports · 1993–2026

  • BOOK 2,152 reports
  • RANK #480 of 1000
  • DEATH 18 death-typed
  • INJ 145 injury-typed
  • MALF 1,954 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 452
  • PHOTO Temporary Non-Roller…

Nearest event-volume peer: Temporary Non-Roller Type Right Heart Support Blood Pump (2 report gap)

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass sits #480 of 1000 among tracked device types with 2,152 MAUDE reports spanning 1993–2026. 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

Adaptor carries 90.8% MALFUNCTION-coded reports, 26.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 6.7% corpus 30.3% · below corpus mean (-23.6 pp)
  • MALF 90.8% corpus 64.8% · above corpus mean (+26.0 pp)

Lead product-problem code Leak/Splash is 37% of coded problems · Lead manufacturer MERIT MEDICAL SYSTEMS, INC. accounts for 28% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Adaptor in the event-volume neighbourhood

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

reports

What this shows Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass carries 2,152 MAUDE reports, ranked #480 of 1000.

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

Event Types

Malfunction 1,954 (90.8%)
Injury 145 (6.7%)
Other 23 (1.1%)
Death 18 (0.8%)
12 (0.6%)

Patient Outcomes

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

1,863 (84.8%)
Other 134 (6.1%)
Required Intervention 64 (2.9%)
Life Threatening 39 (1.8%)
R 36 (1.6%)
Death 18 (0.8%)
Hospitalization 18 (0.8%)
L 11 (0.5%)
H 7 (0.3%)
Disability 4 (0.2%)
O 2 (0.1%)
S 1 (0.0%)

Top Product Problems

Leak/Splash 719
Break 266
Loose or Intermittent Connection 191
Human-Device Interface Problem 123
Air Leak 117
Fluid/Blood Leak 78
Air/Gas in Device 60
Detachment Of Device Component 60
Crack 51
Bubble(s) 41
Hole In Material 35
Tear, Rip or Hole in Device Packaging 33
Burst Container or Vessel 29
Device Contamination with Chemical or Other Material 25
Defective Device 24
Improper or Incorrect Procedure or Method 23
Replace 23
Physical Resistance/Sticking 22
Unsealed Device Packaging 22
Unable to Obtain Readings 21

Yearly Trend

93
1993: 1
94
1994: 1
95
1995: 1
96
1996: 5
97
1997: 22
98
1998: 7
99
1999: 27
00
2000: 32
01
2001: 13
02
2002: 12
03
2003: 18
04
2004: 20
05
2005: 44
06
2006: 45
07
2007: 37
08
2008: 16
09
2009: 62
10
2010: 147
11
2011: 160
12
2012: 53
13
2013: 67
14
2014: 80
15
2015: 89
16
2016: 67
17
2017: 106
18
2018: 84
19
2019: 76
20
2020: 53
21
2021: 55
22
2022: 48
23
2023: 46
24
2024: 452
25
2025: 113
26
2026: 93

Reports fell to 113 in 2025, down from an average of 249 in the two years before.

Related Entities for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Event Locations

1,489 (69.2%)
I 454 (21.1%)
HOSPITAL 161 (7.5%)
INVALID DATA 17 (0.8%)
NO INFORMATION 15 (0.7%)
UNKNOWN 13 (0.6%)
OTHER 3 (0.1%)

Compare MERIT MEDICAL SYSTEMS, INC. vs ABBOTT VASCULAR INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Adaptor: 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 (2,152 here).

Similar death-typed counts

Nearest other device types by death-typed report count (18 here), distinct from the volume row.

Disclaimer: MAUDE figures for Adaptor 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 Adaptor; 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.