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TPLC
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Device
control, pump speed, cardiopulmonary bypass
Product Code
DWA
Regulation Number
870.4380
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT (FORMERLY THORATEC CORPORATION)
SUBSTANTIALLY EQUIVALENT
1
APMTD INC.
SUBSTANTIALLY EQUIVALENT
1
APMTD, INC.
SUBSTANTIALLY EQUIVALENT
1
INSPIRA TECHNOLOGIES OXY B.H.N LTD.
SUBSTANTIALLY EQUIVALENT
1
SPECTRUM MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
THORATEC CORPORATION (NOW PART OF ABBOTT)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
375
375
2020
146
146
2021
155
155
2022
205
205
2023
439
439
2024
275
275
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
240
240
Battery Problem
182
182
Power Problem
155
155
Pumping Stopped
147
147
Device Alarm System
146
146
Infusion or Flow Problem
132
132
Pumping Problem
79
79
Unexpected Shutdown
70
70
Mechanical Problem
69
69
Noise, Audible
67
67
Electrical /Electronic Property Problem
66
66
Display or Visual Feedback Problem
64
64
Communication or Transmission Problem
53
53
Decreased Pump Speed
53
53
Overheating of Device
45
45
No Display/Image
42
42
Obstruction of Flow
30
30
No Apparent Adverse Event
23
23
Smoking
23
23
Appropriate Term/Code Not Available
22
22
No Flow
22
22
Failure to Power Up
21
21
Electrical Power Problem
18
18
Material Deformation
16
16
Improper or Incorrect Procedure or Method
14
14
Insufficient Flow or Under Infusion
14
14
Vibration
13
13
Partial Blockage
13
13
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Adverse Event Without Identified Device or Use Problem
11
11
Detachment of Device or Device Component
10
10
Break
9
9
Excessive Heating
9
9
Connection Problem
9
9
Difficult to Open or Close
8
8
Unable to Obtain Readings
7
7
No Audible Alarm
7
7
Mechanical Jam
7
7
Disconnection
6
6
Increased Pump Speed
6
6
Loss of Power
6
6
Alarm Not Visible
6
6
Nonstandard Device
6
6
Failure of Device to Self-Test
5
5
Complete Loss of Power
5
5
Data Problem
5
5
Temperature Problem
5
5
Failure to Run on Battery
5
5
Failure to Charge
5
5
Device Difficult to Setup or Prepare
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1041
1041
No Consequences Or Impact To Patient
195
195
No Known Impact Or Consequence To Patient
150
150
No Patient Involvement
139
139
Insufficient Information
27
27
Low Oxygen Saturation
16
16
Cardiac Arrest
13
13
Death
12
12
Low Blood Pressure/ Hypotension
10
10
No Information
8
8
Thrombus
6
6
Hypoxia
4
4
Hemorrhage/Bleeding
4
4
Stroke/CVA
3
3
Hemolysis
3
3
No Code Available
3
3
Dyspnea
3
3
Loss of consciousness
3
3
Respiratory Insufficiency
3
3
Infarction, Cerebral
2
2
Bradycardia
2
2
Asystole
2
2
Syncope/Fainting
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Complaint, Ill-Defined
1
1
Exsanguination
1
1
Ischemia
1
1
Blood Loss
1
1
Multiple Organ Failure
1
1
Thrombosis/Thrombus
1
1
Chest Pain
1
1
Cardiogenic Shock
1
1
Cardiopulmonary Arrest
1
1
Shock
1
1
Anxiety
1
1
Cough
1
1
Unspecified Tissue Injury
1
1
Cardiovascular Insufficiency
1
1
Bacterial Infection
1
1
Hypovolemia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardiac Assist, Inc
I
Jan-19-2023
2
Cardiac Assist, Inc
I
Sep-23-2022
3
LivaNova Deutschland GmbH
III
Mar-15-2022
4
LivaNova Deutschland GmbH
II
Jul-08-2020
5
Medtronic Perfusion Systems
I
Mar-26-2021
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