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TPLC
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show TPLC since
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Device
artificial heart
Definition
P030011
Product Code
LOZ
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
5
8
5
0
2
6
MDR Year
MDR Reports
MDR Events
2018
569
569
2019
379
379
2020
264
264
2021
241
241
2022
152
152
2023
135
135
Device Problems
MDRs with this Device Problem
Events in those MDRs
Audible Prompt/Feedback Problem
506
506
Adverse Event Without Identified Device or Use Problem
469
469
Mechanical Problem
161
161
Battery Problem
152
152
Appropriate Term/Code Not Available
139
139
Electrical /Electronic Property Problem
120
120
Output Problem
92
92
No Apparent Adverse Event
83
83
Device Displays Incorrect Message
63
63
Noise, Audible
55
55
Display or Visual Feedback Problem
45
45
Material Integrity Problem
31
31
Failure to Charge
23
23
Image Display Error/Artifact
22
22
Device Operates Differently Than Expected
22
22
Material Puncture/Hole
21
21
Break
20
20
Power Problem
17
17
Insufficient Information
16
16
Charging Problem
15
15
Device Operational Issue
13
13
Connection Problem
9
9
Fracture
8
8
Premature Discharge of Battery
7
7
No Display/Image
7
7
Physical Property Issue
7
7
Device Emits Odor
6
6
Device Inoperable
6
6
Difficult to Insert
5
5
Crack
5
5
Material Discolored
5
5
Temperature Problem
5
5
Activation, Positioning or Separation Problem
5
5
Contamination /Decontamination Problem
4
4
Device Stops Intermittently
4
4
Disconnection
4
4
Filling Problem
4
4
Calibration Problem
4
4
Failure to Calibrate
3
3
Incorrect Or Inadequate Test Results
3
3
Loose or Intermittent Connection
3
3
Material Too Rigid or Stiff
3
3
Sticking
3
3
Restricted Flow rate
3
3
Detachment Of Device Component
3
3
Air Leak
3
3
Material Deformation
3
3
Physical Resistance/Sticking
3
3
No Visual Prompts/Feedback
2
2
Material Split, Cut or Torn
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Failure of Device to Self-Test
2
2
Computer Operating System Problem
2
2
Device Sensing Problem
2
2
Pressure Problem
2
2
Mechanical Jam
2
2
No Audible Alarm
2
2
Computer Software Problem
2
2
Display Difficult to Read
2
2
Degraded
2
2
Leak/Splash
2
2
Difficult to Remove
2
2
Use of Device Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Component Missing
2
2
Overfill
2
2
Malposition of Device
2
2
Patient-Device Incompatibility
1
1
Application Program Problem
1
1
Obstruction of Flow
1
1
Device Issue
1
1
Unstable
1
1
Split
1
1
Low Battery
1
1
Defective Device
1
1
Visual Prompts will not Clear
1
1
No Audible Prompt/Feedback
1
1
Inaudible or Unclear Audible Prompt/Feedback
1
1
Aborted Charge
1
1
Defective Component
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Self-Activation or Keying
1
1
Material Separation
1
1
Shipping Damage or Problem
1
1
Short Fill
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Slipped
1
1
Incorrect Measurement
1
1
Product Quality Problem
1
1
Radiation Leak
1
1
Inflation Problem
1
1
Overheating of Device
1
1
Loss of Power
1
1
Failure to Power Up
1
1
Failure to Pump
1
1
Pumping Stopped
1
1
Material Frayed
1
1
Material Erosion
1
1
Thermal Decomposition of Device
1
1
Calibration Error
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
540
540
No Consequences Or Impact To Patient
427
427
No Patient Involvement
315
315
Death
207
207
Bacterial Infection
132
132
Respiratory Failure
126
126
No Known Impact Or Consequence To Patient
109
109
Hemorrhage/Bleeding
105
105
Renal Failure
101
101
Multiple Organ Failure
98
98
Neurological Deficit/Dysfunction
86
86
Patient Problem/Medical Problem
44
44
Hemolysis
38
38
Liver Damage/Dysfunction
34
34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
34
34
Loss of consciousness
31
31
Sepsis
30
30
Stroke/CVA
30
30
Fungal Infection
27
27
Renal Impairment
24
24
Urinary Tract Infection
21
21
Unspecified Infection
19
19
No Code Available
18
18
Thromboembolism
15
15
Viral Infection
11
11
Thrombosis/Thrombus
11
11
No Information
10
10
High Blood Pressure/ Hypertension
9
9
Hemorrhage, Cerebral
6
6
Insufficient Information
6
6
Pericardial Effusion
5
5
Cardiomyopathy
5
5
Wound Dehiscence
5
5
Encephalopathy
5
5
Hypervolemia
5
5
Pulmonary Edema
4
4
Convulsion/Seizure
4
4
Hemorrhagic Stroke
3
3
Liver Failure
3
3
Ischemia
3
3
Intracranial Hemorrhage
3
3
Pulmonary Embolism
3
3
Bowel Perforation
3
3
Low Cardiac Output
3
3
Lethargy
2
2
Decreased Respiratory Rate
2
2
Coma
2
2
Discomfort
2
2
Complaint, Ill-Defined
2
2
Dizziness
2
2
Brain Injury
2
2
Right Ventricular Failure
2
2
Hematoma
2
2
Low Blood Pressure/ Hypotension
2
2
Pulmonary Dysfunction
2
2
Unspecified Hepatic or Biliary Problem
2
2
Heart Failure/Congestive Heart Failure
2
2
Unspecified Nervous System Problem
2
2
Suicidal Ideation
2
2
Arteriosclerosis/ Atherosclerosis
1
1
Embolism/Embolus
1
1
Skin Inflammation/ Irritation
1
1
Inflammation
1
1
Liver Laceration(s)
1
1
Hypoxia
1
1
Failure of Implant
1
1
Abdominal Pain
1
1
Arrhythmia
1
1
Aspiration/Inhalation
1
1
Cardiopulmonary Arrest
1
1
Congenital Defect/Deformity
1
1
Congestive Heart Failure
1
1
Fainting
1
1
Fall
1
1
Headache
1
1
Disseminated Intravascular Coagulation (DIC)
1
1
Edema
1
1
Embolus
1
1
Seizures
1
1
Blurred Vision
1
1
Septic Shock
1
1
Shock
1
2
Thrombosis
1
1
Thrombus
1
1
Transient Ischemic Attack
1
1
Heart Failure
1
1
Depression
1
1
Cardiogenic Shock
1
1
Anxiety
1
1
Test Result
1
1
Obstruction/Occlusion
1
1
Palpitations
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
SynCardia Systems LLC
II
Oct-20-2023
2
SynCardia Systems LLC
II
Jan-27-2023
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