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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
artificial heart
Definition
P030011
Product Code
LOZ
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
1
2
2
5
3
7
7
10
11
5
8
5
0
2
6
1
MDR Year
MDR Reports
MDR Events
2014
325
325
2015
421
421
2016
422
422
2017
291
291
2018
569
569
2019
379
379
2020
264
264
2021
241
241
2022
152
152
2023
167
167
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Displays Incorrect Message
703
703
Audible Prompt/Feedback Problem
552
552
Adverse Event Without Identified Device or Use Problem
493
493
Device Operates Differently Than Expected
332
332
Battery Problem
292
292
Noise, Audible
222
222
Mechanical Problem
202
202
Appropriate Term/Code Not Available
161
161
Electrical /Electronic Property Problem
137
137
Output Problem
111
111
Power Problem
94
94
No Apparent Adverse Event
89
89
Break
87
87
Charging Problem
80
80
Failure to Charge
78
78
Device Alarm System
69
69
Display or Visual Feedback Problem
67
67
Connection Problem
46
46
Device Operational Issue
40
40
Device Inoperable
38
38
Physical Property Issue
36
36
Material Integrity Problem
33
33
Loose or Intermittent Connection
32
32
No Display/Image
32
32
Filling Problem
29
29
Image Display Error/Artifact
29
29
Material Puncture/Hole
24
24
Crack
24
24
Difficult to Insert
23
23
Premature Discharge of Battery
22
22
Insufficient Information
22
22
Low Battery
20
20
Device Stops Intermittently
19
19
Temperature Problem
18
18
Detachment Of Device Component
17
17
Air Leak
17
17
False Alarm
16
16
Disconnection
15
15
Component Falling
15
15
Device Dislodged or Dislocated
14
14
Difficult to Remove
14
14
Computer Operating System Problem
13
13
Torn Material
13
13
Material Discolored
13
13
Failure to Power Up
13
13
Defective Alarm
13
13
Fracture
12
12
Device Emits Odor
11
11
Pressure Problem
11
11
Failure of Device to Self-Test
10
10
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1155
1155
No Known Impact Or Consequence To Patient
984
984
No Clinical Signs, Symptoms or Conditions
618
618
No Patient Involvement
593
593
Death
231
231
Bacterial Infection
133
133
Respiratory Failure
127
127
Hemorrhage/Bleeding
106
106
Renal Failure
102
102
Multiple Organ Failure
98
98
Neurological Deficit/Dysfunction
86
86
Loss of consciousness
63
63
Patient Problem/Medical Problem
50
50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
48
48
Hemolysis
40
40
Sepsis
36
36
Liver Damage/Dysfunction
34
34
No Information
32
32
Stroke/CVA
31
31
No Code Available
30
30
Fungal Infection
27
27
High Blood Pressure/ Hypertension
26
26
Renal Impairment
24
24
Urinary Tract Infection
21
21
Unspecified Infection
20
20
Thromboembolism
15
15
Dizziness
13
13
Low Cardiac Output
13
13
Viral Infection
11
11
Thrombosis/Thrombus
11
11
Discomfort
10
10
Dyspnea
8
8
Complaint, Ill-Defined
8
8
Fall
6
6
Insufficient Information
6
6
Pulmonary Embolism
6
6
Hemorrhage, Cerebral
6
6
Pulmonary Edema
6
6
Hypervolemia
5
5
Fatigue
5
5
Encephalopathy
5
5
Cardiomyopathy
5
5
Wound Dehiscence
5
5
Pericardial Effusion
5
5
Headache
4
4
Right Ventricular Failure
4
4
Convulsion/Seizure
4
4
Intracranial Hemorrhage
3
3
Hemorrhagic Stroke
3
3
Edema
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
SynCardia Systems Inc.
I
Dec-08-2016
2
SynCardia Systems Inc.
I
Sep-17-2015
3
SynCardia Systems LLC
II
Oct-20-2023
4
SynCardia Systems LLC
II
Jan-27-2023
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