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Device
oxygenator, cardiopulmonary bypass
Regulation Description
Cardiopulmonary bypass oxygenator.
Product Code
DTZ
Regulation Number
870.4350
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
1
ABIOMED INC.
SUBSTANTIALLY EQUIVALENT
2
CHALICE MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
3
EUROSETS S.R.L.
SUBSTANTIALLY EQUIVALENT
2
1. K202206
AMG PMP Pediatric
2. K202510
AMG PMP Infant
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC PERFUSION SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
SORIN GROUP ITALIA S.R.L
SUBSTANTIALLY EQUIVALENT
2
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2020
442
442
2021
595
595
2022
559
559
2023
740
740
2024
536
536
2025
48
48
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fluid/Blood Leak
557
557
Leak/Splash
292
292
Break
177
177
Material Separation
153
153
Increase in Pressure
153
153
Infusion or Flow Problem
142
142
Packaging Problem
118
118
Gas Output Problem
93
93
Use of Device Problem
90
90
Pressure Problem
89
89
Crack
88
88
Obstruction of Flow
87
87
Material Deformation
63
63
Air/Gas in Device
60
60
Coagulation in Device or Device Ingredient
53
53
Adverse Event Without Identified Device or Use Problem
46
46
Defective Component
42
42
Insufficient Information
42
42
Detachment of Device or Device Component
39
39
Contamination
34
34
Unexpected Therapeutic Results
33
33
Mechanical Problem
32
32
Material Puncture/Hole
32
32
Manufacturing, Packaging or Shipping Problem
31
31
Noise, Audible
29
29
Insufficient Flow or Under Infusion
29
29
Shipping Damage or Problem
28
28
Improper Chemical Reaction
28
28
Failure to Deliver
28
28
Decrease in Pressure
27
27
Gas/Air Leak
26
26
Improper Flow or Infusion
24
24
Disconnection
22
22
Connection Problem
20
20
Contamination /Decontamination Problem
20
20
Device Sensing Problem
19
19
No Flow
19
19
Output Problem
15
15
Fracture
14
14
Medical Gas Supply Problem
14
14
Particulates
13
13
Low Readings
13
13
Scratched Material
12
12
Temperature Problem
12
12
Unable to Obtain Readings
12
12
Pumping Stopped
12
12
Loose or Intermittent Connection
12
12
Defective Device
12
12
Dent in Material
11
11
High Readings
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2149
2149
No Patient Involvement
176
176
No Consequences Or Impact To Patient
173
173
Hemorrhage/Bleeding
120
120
Insufficient Information
102
102
No Known Impact Or Consequence To Patient
61
61
Low Oxygen Saturation
46
46
Death
26
26
Blood Loss
25
25
Hypoxia
24
24
Cardiac Arrest
23
23
No Information
17
17
Low Blood Pressure/ Hypotension
14
14
Sepsis
13
13
Air Embolism
11
11
Hemolysis
10
10
Thrombosis/Thrombus
10
10
Injury
7
7
Stroke/CVA
6
6
Anemia
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Unspecified Infection
6
6
Abnormal Blood Gases
5
5
Ischemia Stroke
5
5
Thrombocytopenia
4
4
Coagulation Disorder
4
4
Bradycardia
4
4
Respiratory Failure
4
4
Hypothermia
3
3
Thromboembolism
3
3
Lactate Dehydrogenase Increased
3
3
Multiple Organ Failure
3
3
Ischemia
3
3
Arrhythmia
2
2
Lupus
2
2
Autoimmune Disorder
2
2
Brain Injury
2
2
Exsanguination
2
2
Asystole
2
2
Hematoma
2
2
Swelling/ Edema
2
2
Hypovolemia
2
2
Inflammation
2
2
Septic Shock
2
2
Pneumonia
1
1
Respiratory Insufficiency
1
1
Cardiopulmonary Arrest
1
1
Loss of consciousness
1
1
Seizures
1
1
Cardiovascular Insufficiency
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abiomed, Inc.
I
Feb-03-2022
2
Maquet Cardiovascular Us Sales, Llc
II
Dec-17-2020
3
Maquet Medical Systems USA
II
Feb-13-2024
4
Maquet Medical Systems USA
II
May-30-2023
5
Maquet Medical Systems USA
II
May-26-2023
6
Maquet Medical Systems USA
II
Feb-28-2023
7
Maquet Medical Systems USA
II
Sep-19-2022
8
Medtronic Perfusion Systems
II
Jan-27-2023
9
Medtronic Perfusion Systems
II
Jul-04-2020
10
Terumo Cardiovascular Systems Corporation
II
Apr-05-2023
11
Terumo Cardiovascular Systems Corporation
II
Dec-14-2020
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