Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
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
299
299
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
242
242
Battery Problem
191
191
Power Problem
158
158
Device Alarm System
152
152
Pumping Stopped
149
149
Infusion or Flow Problem
134
134
Pumping Problem
84
84
Unexpected Shutdown
73
73
Noise, Audible
68
68
Mechanical Problem
68
68
Display or Visual Feedback Problem
67
67
Electrical /Electronic Property Problem
66
66
Communication or Transmission Problem
56
56
Decreased Pump Speed
52
52
Overheating of Device
45
45
No Display/Image
41
41
Obstruction of Flow
30
30
Failure to Power Up
24
24
No Apparent Adverse Event
24
24
Smoking
23
23
No Flow
22
22
Appropriate Term/Code Not Available
22
22
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
Adverse Event Without Identified Device or Use Problem
11
11
Incorrect, Inadequate or Imprecise Result or Readings
11
11
Detachment of Device or Device Component
10
10
Excessive Heating
9
9
Connection Problem
9
9
Break
9
9
Difficult to Open or Close
8
8
Mechanical Jam
7
7
No Audible Alarm
7
7
Unable to Obtain Readings
7
7
Nonstandard Device
6
6
Loss of Power
6
6
Alarm Not Visible
6
6
Increased Pump Speed
6
6
Disconnection
6
6
Increase in Pressure
5
5
Data Problem
5
5
Failure of Device to Self-Test
5
5
Complete Loss of Power
5
5
Device Difficult to Setup or Prepare
5
5
Failure to Run on Battery
5
5
Temperature Problem
5
5
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1068
1068
No Consequences Or Impact To Patient
195
195
No Known Impact Or Consequence To Patient
150
150
No Patient Involvement
139
139
Insufficient Information
26
26
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
Hemorrhage/Bleeding
4
4
Hypoxia
4
4
Stroke/CVA
3
3
Respiratory Insufficiency
3
3
Hemolysis
3
3
No Code Available
3
3
Loss of consciousness
3
3
Dyspnea
3
3
Asystole
2
2
Bradycardia
2
2
Infarction, Cerebral
2
2
Cardiogenic Shock
1
1
Chest Pain
1
1
Cardiopulmonary Arrest
1
1
Thrombosis/Thrombus
1
1
Respiratory Acidosis
1
1
Shock
1
1
Anxiety
1
1
Cough
1
1
Unspecified Tissue Injury
1
1
Multiple Organ Failure
1
1
Cardiovascular Insufficiency
1
1
Blood Loss
1
1
Ischemia
1
1
Exsanguination
1
1
Complaint, Ill-Defined
1
1
Bacterial Infection
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Syncope/Fainting
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
-
-