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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, LLC
SUBSTANTIALLY EQUIVALENT
1
ARROW INTERNATIONAL, TELEFLEX
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
3552
3552
2020
3393
3393
2021
4345
4345
2022
5113
5113
2023
6978
6978
2024
1146
1146
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
2156
2156
Gas/Air Leak
1847
1847
Leak/Splash
1502
1502
Inability to Auto-Fill
1287
1287
Optical Problem
1096
1096
Break
1025
1025
Battery Problem
954
954
Failure to Sense
897
897
Display or Visual Feedback Problem
801
801
Incorrect, Inadequate or Imprecise Result or Readings
783
783
Unexpected Shutdown
750
750
Pressure Problem
669
669
Device Displays Incorrect Message
662
662
Failure to Power Up
629
629
Failure to Charge
543
543
Inflation Problem
538
538
Difficult to Insert
528
528
No Display/Image
512
512
Erratic or Intermittent Display
504
504
Premature Discharge of Battery
489
489
Device Contamination with Body Fluid
452
452
Fluid/Blood Leak
426
426
Device Contamination with Chemical or Other Material
370
370
Noise, Audible
344
344
Overheating of Device
340
340
Power Problem
326
326
Pumping Stopped
315
315
Device Alarm System
286
286
Calibration Problem
279
279
Material Deformation
276
276
Connection Problem
250
250
Inappropriate Waveform
230
230
Communication or Transmission Problem
227
227
Charging Problem
218
218
Material Rupture
216
216
Electrical /Electronic Property Problem
206
206
Difficult to Advance
190
190
Output Problem
186
186
Retraction Problem
156
156
No Apparent Adverse Event
152
152
Moisture or Humidity Problem
146
146
Failure to Zero
146
146
Backflow
144
144
Mechanical Problem
140
140
Adverse Event Without Identified Device or Use Problem
131
131
Failure to Calibrate
126
126
Filling Problem
122
122
Material Integrity Problem
113
113
No Device Output
99
99
Difficult to Remove
99
99
Unraveled Material
92
92
Restricted Flow rate
82
82
Decrease in Suction
81
81
Circuit Failure
78
78
Therapeutic or Diagnostic Output Failure
75
75
Loss of Power
74
74
Incomplete or Inadequate Connection
73
73
Output below Specifications
69
69
Inadequate User Interface
69
69
Difficult to Flush
68
68
Defective Component
67
67
Failure to Advance
64
64
Migration
64
64
Loose or Intermittent Connection
64
64
Obstruction of Flow
63
63
Off-Label Use
62
62
Failure to Run on Battery
61
61
Unable to Obtain Readings
60
60
Material Twisted/Bent
60
60
Mechanical Jam
60
60
Infusion or Flow Problem
56
56
Insufficient Information
54
54
Component Incompatible
53
53
Gas Output Problem
52
52
Temperature Problem
52
52
Crack
51
51
Image Display Error/Artifact
49
49
Audible Prompt/Feedback Problem
49
49
Failure to Pump
48
48
Use of Device Problem
46
46
Complete Loss of Power
46
46
Failure to Read Input Signal
45
45
Device Sensing Problem
45
45
Component Missing
42
42
Device Markings/Labelling Problem
40
40
Protective Measures Problem
40
40
Device Emits Odor
40
40
Material Puncture/Hole
39
39
Deformation Due to Compressive Stress
39
39
Defective Device
39
39
Suction Problem
36
36
Detachment of Device or Device Component
36
36
Device Damaged Prior to Use
33
33
Deflation Problem
31
31
Material Frayed
30
30
Application Program Freezes, Becomes Nonfunctional
30
30
No Audible Alarm
29
29
Computer Software Problem
28
28
Fracture
28
28
Device Handling Problem
28
28
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
15752
15752
No Consequences Or Impact To Patient
3208
3208
No Patient Involvement
3026
3026
Insufficient Information
2818
2818
No Known Impact Or Consequence To Patient
1366
1366
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
249
249
Death
169
169
Low Blood Pressure/ Hypotension
68
68
Injury
65
65
Needle Stick/Puncture
53
53
Cardiac Arrest
49
49
No Information
43
43
Hemorrhage/Bleeding
26
26
Tachycardia
20
20
Failure of Implant
19
19
Chest Pain
19
19
Cardiogenic Shock
18
18
Myocardial Infarction
12
12
Pain
12
12
Abdominal Pain
12
12
Arrhythmia
11
11
Calcium Deposits/Calcification
11
12
Thrombus
11
11
Diminished Pulse Pressure
11
11
Ischemia
10
10
Ventricular Fibrillation
9
9
Bradycardia
9
9
Stroke/CVA
9
9
Pseudoaneurysm
9
9
Vascular Dissection
9
9
Thrombosis/Thrombus
9
9
No Code Available
8
9
Air Embolism
8
8
Hematoma
8
8
Perforation
7
7
Atrial Fibrillation
7
7
Foreign Body In Patient
7
7
Low Cardiac Output
7
7
Blood Loss
6
6
Device Embedded In Tissue or Plaque
6
6
Dyspnea
6
6
High Blood Pressure/ Hypertension
6
6
Fever
5
5
Nausea
5
5
Shock
5
5
Cardiac Tamponade
5
5
Low Oxygen Saturation
5
5
Unspecified Vascular Problem
5
5
Heart Failure/Congestive Heart Failure
5
5
Ventricular Tachycardia
4
4
Perforation of Vessels
3
3
Dizziness
3
3
Rupture
3
3
Paresis
3
3
Liver Laceration(s)
3
3
Pneumothorax
3
3
Vessel Or Plaque, Device Embedded In
3
3
Mitral Valve Insufficiency/ Regurgitation
3
3
Tricuspid Valve Insufficiency/ Regurgitation
3
3
Unspecified Kidney or Urinary Problem
3
3
Chest Tightness/Pressure
3
3
Loss of consciousness
3
3
Confusion/ Disorientation
3
3
Patient Problem/Medical Problem
3
3
Thromboembolism
3
3
Test Result
2
2
Embolism/Embolus
2
2
Convulsion/Seizure
2
2
Vascular System (Circulation), Impaired
2
2
Aortic Dissection
2
2
Irregular Pulse
2
2
Unspecified Tissue Injury
2
2
Swelling/ Edema
2
2
Pulmonary Embolism
2
2
Aneurysm
2
2
Bruise/Contusion
2
2
Non specific EKG/ECG Changes
2
2
Emotional Changes
2
2
Cardiomyopathy
2
2
Headache
2
2
Extravasation
2
2
Hypoxia
2
2
Laceration(s)
2
2
Heart Failure
2
2
Vomiting
2
2
Great Vessel Perforation
2
2
Dysphasia
1
1
Skin Discoloration
1
1
Toxemia
1
1
Stenosis
1
1
Physical Entrapment
1
1
Anxiety
1
1
Discomfort
1
1
Liver Damage/Dysfunction
1
1
Occlusion
1
1
Pulmonary Edema
1
1
Renal Disease, End Stage
1
1
Renal Failure
1
1
Respiratory Distress
1
1
Urinary Retention
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
Aug-31-2023
4
Datascope Corp.
I
Aug-30-2023
5
Datascope Corp.
I
Aug-30-2023
6
Datascope Corp.
I
Aug-30-2023
7
Datascope Corp.
I
Aug-30-2023
8
Datascope Corp.
II
Jul-21-2023
9
Datascope Corp.
I
Jul-20-2023
10
Datascope Corp.
I
Jul-19-2023
11
Datascope Corp.
III
Jun-14-2023
12
Datascope Corp.
II
Apr-26-2023
13
Datascope Corp.
II
Mar-22-2023
14
Datascope Corp.
I
Mar-09-2023
15
Datascope Corp.
I
Mar-09-2023
16
Datascope Corp.
II
Mar-06-2023
17
Datascope Corp.
II
Mar-06-2023
18
Datascope Corp.
I
Jan-19-2023
19
Datascope Corp.
I
Dec-30-2021
20
Datascope Corp.
I
Oct-20-2021
21
Datascope Corp.
II
Oct-07-2021
22
Datascope Corp.
II
Sep-30-2021
23
Datascope Corp.
III
Apr-28-2021
24
Datascope Corp.
I
Jul-16-2019
25
Datascope Corporation
II
Sep-08-2022
26
Datascope Corporation
II
Aug-21-2020
27
Datascope Corporation
II
Feb-02-2020
28
Datascope Corporation
II
Jul-12-2019
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