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Device
system, balloon, intra-aortic and control
Product Code
DSP
Regulation Number
870.3535
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARROW INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
ARROW INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
2
ARROW INTERNATIONAL, TELEFLEX
SUBSTANTIALLY EQUIVALENT
1
DATASCOPE CORP.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
3331
3331
2019
3552
3552
2020
3393
3393
2021
4345
4345
2022
5112
5112
2023
2635
2635
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
1777
1777
Gas/Air Leak
1592
1592
Device Displays Incorrect Message
1282
1282
Leak/Splash
1265
1265
Inability to Auto-Fill
1020
1020
Battery Problem
897
897
Optical Problem
883
883
Break
838
838
Display or Visual Feedback Problem
772
772
Failure to Sense
729
729
Pressure Problem
616
616
Unexpected Shutdown
591
591
Failure to Power Up
546
546
No Display/Image
519
519
Incorrect, Inadequate or Imprecise Result or Readings
514
514
Fluid/Blood Leak
496
496
Difficult to Insert
491
491
Inflation Problem
457
457
Device Alarm System
436
436
Failure to Charge
427
427
Premature Discharge of Battery
402
402
Erratic or Intermittent Display
366
366
Device Contamination with Chemical or Other Material
352
352
Device Contamination with Body Fluid
342
342
Material Rupture
341
341
Pumping Stopped
314
314
Noise, Audible
300
300
Material Deformation
280
280
Power Problem
265
265
Calibration Problem
253
253
Charging Problem
231
231
Device Operates Differently Than Expected
229
229
Overheating of Device
221
221
Communication or Transmission Problem
207
207
Difficult to Advance
205
205
Loss of Power
205
205
Connection Problem
204
204
Electrical /Electronic Property Problem
202
202
Inappropriate Waveform
192
192
Mechanical Problem
152
152
Adverse Event Without Identified Device or Use Problem
152
152
Backflow
147
147
Moisture or Humidity Problem
146
146
Failure to Calibrate
144
144
No Apparent Adverse Event
133
133
Failure to Zero
130
130
Failure to Advance
125
125
Filling Problem
121
121
Retraction Problem
114
114
Output Problem
113
113
Difficult to Remove
101
101
Defective Component
101
101
Unraveled Material
83
83
Therapeutic or Diagnostic Output Failure
73
73
Incomplete or Inadequate Connection
73
73
Material Integrity Problem
72
72
Output below Specifications
71
71
Loose or Intermittent Connection
69
69
Unable to Obtain Readings
67
67
Difficult to Flush
66
66
Circuit Failure
64
64
Off-Label Use
63
63
Defective Device
63
63
Component Missing
61
61
No Device Output
58
58
Obstruction of Flow
57
57
Infusion or Flow Problem
54
54
Failure of Device to Self-Test
54
54
Deformation Due to Compressive Stress
52
52
Component Incompatible
51
51
Restricted Flow rate
49
49
Image Display Error/Artifact
49
49
Gas Output Problem
48
48
Failure to Read Input Signal
48
48
Device Sensing Problem
48
48
Failure to Pump
48
48
Material Twisted/Bent
47
47
Protective Measures Problem
45
45
Temperature Problem
45
45
Migration
45
45
Crack
44
44
Device Markings/Labelling Problem
43
43
Device Inoperable
43
43
Use of Device Problem
43
43
Disconnection
42
42
Material Puncture/Hole
42
42
Device Damaged Prior to Use
39
39
Failure to Run on Battery
38
38
Device Emits Odor
37
37
Audible Prompt/Feedback Problem
36
36
Application Program Freezes, Becomes Nonfunctional
35
35
Insufficient Information
35
35
Detachment of Device or Device Component
33
33
Deflation Problem
32
32
No Audible Alarm
31
31
Decrease in Suction
29
29
Moisture Damage
29
29
Physical Resistance/Sticking
29
29
Migration or Expulsion of Device
28
28
Pumping Problem
27
27
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
10597
10597
No Patient Involvement
3899
3899
No Consequences Or Impact To Patient
3716
3716
No Known Impact Or Consequence To Patient
3111
3111
Insufficient Information
1495
1495
Death
251
251
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
184
184
Low Blood Pressure/ Hypotension
85
85
Injury
70
70
No Information
51
51
Cardiac Arrest
46
46
Calcium Deposits/Calcification
37
38
Needle Stick/Puncture
36
36
Myocardial Infarction
33
33
Hemorrhage/Bleeding
32
32
Cardiogenic Shock
26
26
No Code Available
24
25
Blood Loss
23
23
Tachycardia
21
21
Chest Pain
19
19
Failure of Implant
16
16
Abdominal Pain
15
15
Thrombus
14
14
Nausea
14
14
Ischemia
14
14
Pain
11
11
Low Cardiac Output
11
11
Vascular Dissection
11
11
Diminished Pulse Pressure
10
10
Device Embedded In Tissue or Plaque
10
10
Ventricular Fibrillation
10
10
Rupture
10
10
Arrhythmia
10
10
Atrial Fibrillation
9
9
Bradycardia
8
8
Stroke/CVA
8
8
Dyspnea
7
7
Air Embolism
7
7
Vessel Or Plaque, Device Embedded In
7
7
Cardiac Tamponade
7
7
Loss of consciousness
6
6
Pseudoaneurysm
6
6
Patient Problem/Medical Problem
6
6
Thrombosis/Thrombus
6
6
Hypoxia
6
6
High Blood Pressure/ Hypertension
6
6
Fever
6
6
Heart Failure
6
6
Vomiting
6
6
Perforation
5
5
Shock
5
5
Hematoma
5
5
Low Oxygen Saturation
5
5
Aortic Dissection
4
4
Foreign Body In Patient
4
4
Unspecified Vascular Problem
4
4
Renal Failure
4
4
Paresis
4
4
Ventricular Tachycardia
4
4
Brain Injury
4
4
Perforation of Vessels
3
3
Weakness
3
3
Liver Damage/Dysfunction
3
3
Liver Laceration(s)
3
3
Pneumothorax
3
3
Cardiopulmonary Arrest
3
3
Mitral Valve Insufficiency/ Regurgitation
3
3
Tricuspid Valve Insufficiency/ Regurgitation
3
3
Unspecified Kidney or Urinary Problem
3
3
Vascular System (Circulation), Impaired
3
3
Confusion/ Disorientation
3
3
Obstruction/Occlusion
3
3
Chest Tightness/Pressure
3
3
Dizziness
3
3
Discomfort
3
3
Peritonitis
2
2
Numbness
2
2
Collapse
2
2
Loss Of Pulse
2
2
Test Result
2
2
Unspecified Tissue Injury
2
2
Embolism/Embolus
2
2
Convulsion/Seizure
2
2
Swelling/ Edema
2
2
Cardiomyopathy
2
2
Pulmonary Embolism
2
2
Aneurysm
2
2
Emotional Changes
2
2
Extravasation
2
2
Laceration(s)
2
2
Occlusion
2
2
Urinary Retention
2
2
Venipuncture
2
2
Tingling
1
1
Toxemia
1
1
Stenosis
1
1
Physical Entrapment
1
1
Anxiety
1
1
Pulmonary Edema
1
1
Renal Disease, End Stage
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Dec-15-2022
2
Arrow International Inc
I
Jun-26-2020
3
Datascope Corp.
II
Apr-26-2023
4
Datascope Corp.
II
Mar-22-2023
5
Datascope Corp.
I
Mar-09-2023
6
Datascope Corp.
I
Mar-09-2023
7
Datascope Corp.
II
Mar-06-2023
8
Datascope Corp.
II
Mar-06-2023
9
Datascope Corp.
I
Jan-19-2023
10
Datascope Corp.
I
Dec-30-2021
11
Datascope Corp.
I
Oct-20-2021
12
Datascope Corp.
II
Oct-07-2021
13
Datascope Corp.
II
Sep-30-2021
14
Datascope Corp.
III
Apr-28-2021
15
Datascope Corp.
I
Jul-16-2019
16
Datascope Corporation
II
Sep-08-2022
17
Datascope Corporation
II
Aug-21-2020
18
Datascope Corporation
II
Feb-02-2020
19
Datascope Corporation
II
Jul-12-2019
20
Datascope Corporation
II
Oct-11-2018
21
Datascope Corporation
II
Apr-16-2018
22
Maquet Datascope Corp - Cardiac Assist Division
I
Oct-27-2018
23
Maquet Datascope Corp - Cardiac Assist Division
I
May-31-2018
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