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TPLC
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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
3
ARROW INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ARROW INTERNATIONAL, TELEFLEX
SUBSTANTIALLY EQUIVALENT
1
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
SUBSTANTIALLY EQUIVALENT
2
DATASCOPE CORP.
SUBSTANTIALLY EQUIVALENT
5
DATASCOPE CORP., CARDIAC ASSIST DIVISION
SUBSTANTIALLY EQUIVALENT
3
INSIGHTRA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1738
1738
2015
404
404
2016
419
419
2017
2164
2164
2018
3331
3331
2019
3552
3552
2020
3393
3393
2021
4345
4345
2022
5113
5113
2023
6979
6979
2024
4808
4808
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
2657
2657
Device Displays Incorrect Message
2527
2527
Gas/Air Leak
2348
2348
Leak/Splash
2057
2057
Inability to Auto-Fill
1637
1637
Break
1405
1405
Battery Problem
1307
1307
Optical Problem
1235
1235
Failure to Sense
1078
1078
Display or Visual Feedback Problem
1037
1037
Device Operates Differently Than Expected
985
985
Incorrect, Inadequate or Imprecise Result or Readings
944
944
Inflation Problem
909
909
Failure to Power Up
888
888
Fluid/Blood Leak
880
880
Unexpected Shutdown
866
866
Device Alarm System
861
861
No Display/Image
844
844
Pressure Problem
784
784
Difficult to Insert
760
760
Failure to Charge
716
716
Erratic or Intermittent Display
599
599
Device Contamination with Body Fluid
597
597
Premature Discharge of Battery
575
575
Material Rupture
547
547
Noise, Audible
512
512
Pumping Stopped
477
477
Overheating of Device
458
458
Device Contamination with Chemical or Other Material
423
423
Power Problem
413
413
Connection Problem
369
369
Calibration Problem
363
363
Loss of Power
353
353
Communication or Transmission Problem
344
344
Material Deformation
342
342
Charging Problem
302
302
Difficult to Advance
268
268
Electrical /Electronic Property Problem
259
259
Moisture or Humidity Problem
259
259
Inappropriate Waveform
244
244
Adverse Event Without Identified Device or Use Problem
225
225
Output Problem
212
212
Failure to Zero
202
202
Failure to Calibrate
202
202
Failure to Advance
201
201
Backflow
197
197
Retraction Problem
190
190
Moisture Damage
190
190
Material Integrity Problem
189
189
Mechanical Problem
182
182
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
19322
19322
No Consequences Or Impact To Patient
5021
5021
No Patient Involvement
4822
4822
No Known Impact Or Consequence To Patient
4544
4544
Insufficient Information
3462
3462
Death
767
767
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
288
288
Myocardial Infarction
181
181
Low Blood Pressure/ Hypotension
136
136
Cardiogenic Shock
124
124
No Information
112
112
Cardiac Arrest
98
98
Injury
83
83
Hemorrhage/Bleeding
81
81
Calcium Deposits/Calcification
68
69
Complaint, Ill-Defined
61
61
Needle Stick/Puncture
56
56
Blood Loss
51
51
No Code Available
49
50
Chest Pain
39
39
Failure of Implant
28
28
Tachycardia
26
26
Ischemia
26
26
High Blood Pressure/ Hypertension
25
25
Thrombus
24
24
Hematoma
22
22
Pain
21
21
Stroke/CVA
20
20
Vascular Dissection
20
20
Ventricular Fibrillation
19
19
Abdominal Pain
18
18
Angina
16
16
Atherosclerosis
16
16
Cardiopulmonary Arrest
15
15
Arrhythmia
15
15
Low Cardiac Output
15
15
Nausea
15
15
Atrial Fibrillation
14
14
Bradycardia
14
14
Heart Failure
14
14
Congestive Heart Failure
14
14
Device Embedded In Tissue or Plaque
13
13
Foreign Body In Patient
13
13
Loss of consciousness
12
12
Rupture
12
12
Ischemic Heart Disease
12
12
Renal Failure
12
12
Diminished Pulse Pressure
11
11
Pulmonary Edema
10
10
Vessel Or Plaque, Device Embedded In
10
10
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Jun-03-2024
2
ARROW INTERNATIONAL Inc.
I
Dec-15-2022
3
Arrow International Inc
I
Jun-26-2020
4
Arrow International Inc
II
Mar-10-2015
5
Arrow International Inc
II
Mar-02-2015
6
Arrow International Inc
II
Apr-06-2013
7
Arrow International, Inc.
I
Apr-16-2009
8
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Mar-11-2016
9
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Dec-23-2010
10
Datascope Corp.
II
Aug-31-2023
11
Datascope Corp.
I
Aug-30-2023
12
Datascope Corp.
I
Aug-30-2023
13
Datascope Corp.
I
Aug-30-2023
14
Datascope Corp.
I
Aug-30-2023
15
Datascope Corp.
II
Jul-21-2023
16
Datascope Corp.
I
Jul-20-2023
17
Datascope Corp.
I
Jul-19-2023
18
Datascope Corp.
III
Jun-14-2023
19
Datascope Corp.
II
Apr-26-2023
20
Datascope Corp.
II
Mar-22-2023
21
Datascope Corp.
I
Mar-09-2023
22
Datascope Corp.
I
Mar-09-2023
23
Datascope Corp.
II
Mar-06-2023
24
Datascope Corp.
II
Mar-06-2023
25
Datascope Corp.
I
Jan-19-2023
26
Datascope Corp.
I
Dec-30-2021
27
Datascope Corp.
I
Oct-20-2021
28
Datascope Corp.
II
Oct-07-2021
29
Datascope Corp.
II
Sep-30-2021
30
Datascope Corp.
III
Apr-28-2021
31
Datascope Corp.
I
Jul-16-2019
32
Datascope Corporation
II
Sep-08-2022
33
Datascope Corporation
II
Aug-21-2020
34
Datascope Corporation
II
Feb-02-2020
35
Datascope Corporation
II
Jul-12-2019
36
Datascope Corporation
II
Oct-11-2018
37
Datascope Corporation
II
Apr-16-2018
38
Datascope Corporation
II
Jun-08-2016
39
Datascope Corporation
III
Sep-03-2014
40
Datascope Corporation
II
Jun-21-2010
41
Datascope Corporation
II
Apr-15-2009
42
Maquet Cardiovascular, LLC
II
Jan-09-2013
43
Maquet Datascope Corp - Cardiac Assist Division
I
Oct-27-2018
44
Maquet Datascope Corp - Cardiac Assist Division
I
May-31-2018
45
Maquet Datascope Corp - Cardiac Assist Division
I
Sep-05-2017
46
Maquet Datascope Corp - Cardiac Assist Division
I
Jun-23-2017
47
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-02-2017
48
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-25-2016
49
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-23-2015
50
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-07-2015
51
Maquet Datascope Corp - Cardiac Assist Division
I
May-21-2014
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