PlainHospital

MAQUET CARDIOPULMONARY AG

Manufacturer adverse-event records for MAQUET CARDIOPULMONARY AG come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2007–2023 · thin-book · elevated Death-code · balanced

Volume signature

MAQUET CARDIOPULMONARY AG is a thinner MAUDE footprint

MAQUET CARDIOPULMONARY AG accounts for 4,249 FDA MAUDE reports (#407 of 434, thin-book tercile). Death-coded event_type share is 4.75% (elevated); Injury share 24.6% (balanced).

What the volume reading shows for MAQUET CARDIOPULMONARY AG

The standout signal for MAQUET CARDIOPULMONARY AG is filing volume: 4,249 adverse-event reports in FDA MAUDE (#407 of 434, thin-book). Death-coded event_type share sits at 4.75% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Malfunction at 2,971 (69.9% of event_type total). Peak single-year volume reaches 1,326 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,249
Total Reports
202
Event-type Death
1,044
Injury Reports
20
Device Types

Event Types

Malfunction 2,971 (69.9%)
Injury 1,044 (24.6%)
Death 202 (4.8%)
25 (0.6%)
Other 7 (0.2%)

Patient Outcomes

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

2,996 (69.4%)
Required Intervention 807 (18.7%)
Other 242 (5.6%)
Death 177 (4.1%)
R 57 (1.3%)
Life Threatening 21 (0.5%)
Disability 6 (0.1%)
O 4 (0.1%)
S 3 (0.1%)
D 1 (0.0%)

Devices (20)

Device Reports
Console, Heart-Lung Machine, Cardiopulmonary Bypass 1,266
Oxygenator, Cardiopulmonary Bypass 1,117
Controller, Temperature, Cardiopulmonary Bypass 655
Tubing, Pump, Cardiopulmonary Bypass 364
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type 333
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 191
Filter, Blood, Cardiopulmonary Bypass, Arterial Line 142
Dialyzer, High Permeability With Or Without Sealed Dialysate System 56
Reservoir, Blood, Cardiopulmonary Bypass 48
Heat-Exchanger, Cardiopulmonary Bypass 32
Flowmeter, Blood, Cardiovascular 15
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass 7
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 3
Defoamer, Cardiopulmonary Bypass 3
Catheter, Intravascular, Diagnostic 2
Clamp, Vascular 2
Pump, Blood, Cardiopulmonary Bypass, Roller Type 2
Control, Pump Speed, Cardiopulmonary Bypass 1
Electrocardiograph, Ambulatory (Without Analysis) 1
Gas Liquid Chromatography, Barbiturate 1

Yearly Trend

07
2007: 2
08
2008: 5
09
2009: 10
10
2010: 12
11
2011: 11
12
2012: 58
13
2013: 211
14
2014: 1,101
15
2015: 1,326
16
2016: 709
17
2017: 407
18
2018: 331
19
2019: 60
21
2021: 2
22
2022: 3
23
2023: 1

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