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TPLC
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Device
ventricular (assist) bypass
Definition
Approved pma: P870072
Product Code
DSQ
Device Class
3
Premarket Approvals (PMA)
2018
2019
2020
2021
2022
2023
35
34
48
38
33
3
MDR Year
MDR Reports
MDR Events
2018
12660
12660
2019
20216
20216
2020
14238
14238
2021
15766
15766
2022
16000
16000
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
43145
43145
Battery Problem
5363
5363
Pumping Problem
5358
5358
Power Problem
4457
4457
Mechanical Problem
4365
4365
Infusion or Flow Problem
2985
2985
Pumping Stopped
2884
2884
Break
2582
2582
Connection Problem
1739
1739
Material Integrity Problem
1464
1464
Electrical Power Problem
1260
1260
Obstruction of Flow
1243
1243
Complete Loss of Power
1242
1242
Electrical /Electronic Property Problem
1213
1213
Disconnection
1202
1202
Material Twisted/Bent
1160
1160
Material Split, Cut or Torn
949
949
Decreased Pump Speed
921
921
Insufficient Information
830
830
Material Deformation
608
608
Use of Device Problem
431
431
Communication or Transmission Problem
425
425
No Apparent Adverse Event
403
403
Display or Visual Feedback Problem
360
360
High Readings
355
355
Device Stops Intermittently
345
345
Noise, Audible
329
329
Device Difficult to Setup or Prepare
323
323
Appropriate Term/Code Not Available
270
270
Malposition of Device
266
266
Increase in Suction
262
262
Device Displays Incorrect Message
256
256
Loss of Power
255
255
Naturally Worn
222
222
Improper or Incorrect Procedure or Method
208
208
Device Alarm System
204
204
Output Problem
196
196
Overheating of Device
179
179
No Audible Alarm
174
174
Data Problem
146
146
Failure to Charge
134
134
Failure to Power Up
118
118
Loose or Intermittent Connection
112
112
Failure to Pump
107
107
Fluid/Blood Leak
104
104
No Display/Image
98
98
Partial Blockage
96
96
Failure to Align
95
95
Leak/Splash
86
86
Device Inoperable
86
86
Insufficient Flow or Under Infusion
83
83
Detachment of Device or Device Component
77
77
Deformation Due to Compressive Stress
72
72
Contamination
71
71
Restricted Flow rate
70
70
Crack
69
69
Incomplete or Inadequate Connection
65
65
Contamination /Decontamination Problem
64
64
Device Fell
62
62
Electro-Static Discharge
62
62
Date/Time-Related Software Problem
59
59
Electromagnetic Interference
56
56
Low Readings
55
55
Low Audible Alarm
53
53
Electrical Shorting
53
53
Vibration
51
51
Alarm Not Visible
48
48
Material Discolored
48
48
Fracture
46
46
Difficult to Remove
43
43
Unintended Electrical Shock
42
42
Display Difficult to Read
40
40
Unexpected Shutdown
39
39
Corroded
37
37
Kinked
35
35
Device Contamination with Chemical or Other Material
35
35
Premature Discharge of Battery
33
33
Material Separation
33
33
Device Operates Differently Than Expected
29
29
Protective Measures Problem
28
28
Therapeutic or Diagnostic Output Failure
28
28
Failure to Interrogate
28
28
Bent
27
27
Misconnection
26
26
Moisture Damage
24
24
Increased Pump Speed
24
24
Fitting Problem
24
24
Device Damaged Prior to Use
24
24
Charging Problem
24
24
Failure of Device to Self-Test
23
23
Component Missing
23
23
Microbial Contamination of Device
21
21
Device Misassembled During Manufacturing /Shipping
21
21
Torn Material
21
21
Defective Device
20
20
Improper Flow or Infusion
20
20
Manufacturing, Packaging or Shipping Problem
20
20
Material Protrusion/Extrusion
20
20
Tear, Rip or Hole in Device Packaging
20
20
Misassembled
18
18
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
13156
13156
No Known Impact Or Consequence To Patient
11826
11827
Blood Loss
8054
8055
Unspecified Infection
6491
6491
Death
5095
5095
No Consequences Or Impact To Patient
5057
5057
Hemolysis
3239
3239
Thrombus
3223
3223
Bacterial Infection
3078
3078
Stroke/CVA
2853
2853
Hemorrhage/Bleeding
2670
2670
Heart Failure/Congestive Heart Failure
2338
2338
Thrombosis/Thrombus
2253
2253
Insufficient Information
2108
2108
Arrhythmia
1922
1922
Sepsis
1747
1747
Renal Failure
1738
1738
Gastrointestinal Hemorrhage
1584
1584
Respiratory Failure
1554
1554
Skin Infection
1397
1397
Neurological Deficit/Dysfunction
1072
1072
Hemorrhage, Cerebral
996
996
Anemia
972
972
Dyspnea
876
876
Heart Failure
871
871
Thrombosis
760
760
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
705
705
Intracranial Hemorrhage
704
705
Tachycardia
676
676
Dizziness
652
652
Hematuria
642
642
Multiple Organ Failure
629
629
Infarction, Cerebral
596
596
Fever
585
585
Right Ventricular Failure
584
584
High Blood Pressure/ Hypertension
580
580
Thromboembolism
576
576
Unspecified Nervous System Problem
569
569
Hemorrhagic Stroke
544
544
Cardiac Arrest
519
519
Hypervolemia
490
490
Fatigue
487
487
Low Blood Pressure/ Hypotension
473
473
Lactate Dehydrogenase Increased
472
472
Atrial Fibrillation
471
471
Hematoma
466
466
Syncope/Fainting
432
432
Weakness
425
425
No Code Available
402
402
Ischemia Stroke
381
381
Pain
377
377
Cardiogenic Shock
375
375
Ventricular Tachycardia
365
365
Muscle Weakness
360
360
Wound Dehiscence
338
338
Obstruction/Occlusion
315
315
Post Operative Wound Infection
313
313
Transient Ischemic Attack
310
310
Pneumonia
307
307
Pleural Effusion
302
302
Fall
297
297
Ventricular Fibrillation
291
291
Loss of consciousness
290
290
Confusion/ Disorientation
285
285
Headache
279
279
Syncope
273
273
Chest Pain
266
266
Nausea
255
255
Aortic Valve Insufficiency/ Regurgitation
251
251
No Patient Involvement
247
247
Ischemia
236
236
Septic Shock
234
234
Melena
222
222
Renal Impairment
220
220
Cardiac Tamponade
219
219
Vomiting
218
218
Encephalopathy
212
212
Liver Damage/Dysfunction
207
207
Epistaxis
202
202
Hypovolemia
200
200
Pericardial Effusion
195
195
Purulent Discharge
193
193
Abdominal Pain
193
193
Aortic Insufficiency
176
176
Hypoxia
166
166
Hemorrhage, Subarachnoid
162
162
Swelling/ Edema
152
152
Dehydration
148
148
Right Ventricular Dysfunction
148
148
Seizures
143
143
Convulsion/Seizure
139
139
No Information
134
134
Fungal Infection
133
133
Dysphasia
129
129
Liver Failure
122
122
Coma
121
121
Paralysis
117
117
Pulmonary Edema
113
113
Urinary Tract Infection
113
113
Abscess
112
112
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
I
May-17-2018
2
Datascope Corporation
II
Oct-24-2022
3
Heartware
I
May-21-2018
4
Heartware, Inc.
II
Dec-21-2022
5
Heartware, Inc.
I
Aug-18-2022
6
Heartware, Inc.
II
May-17-2022
7
Heartware, Inc.
II
Mar-04-2022
8
Heartware, Inc.
II
Sep-16-2021
9
Heartware, Inc.
I
Aug-06-2021
10
Heartware, Inc.
II
Jul-13-2021
11
Heartware, Inc.
II
Apr-21-2021
12
Heartware, Inc.
II
Apr-20-2021
13
Heartware, Inc.
I
Apr-16-2021
14
Heartware, Inc.
I
Apr-06-2021
15
Heartware, Inc.
I
May-22-2020
16
Heartware, Inc.
I
Mar-09-2020
17
Heartware, Inc.
II
Dec-07-2018
18
Heartware, Inc.
II
Oct-03-2018
19
Jarvik Heart Inc
II
Dec-18-2018
20
Medtronic Inc
I
Jun-21-2022
21
Medtronic Inc
I
Jun-03-2022
22
Medtronic Inc
II
May-17-2022
23
Medtronic Inc
I
Feb-04-2021
24
Thoratec Corp.
II
Nov-26-2021
25
Thoratec Corp.
II
Dec-27-2019
26
Thoratec Corp.
II
Aug-22-2019
27
Thoratec Corp.
II
Apr-19-2019
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