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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, balloon, intra-aortic and control
Regulation Description Intra-aortic balloon and control system.
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTERNATIONAL INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTERNATIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3393 3393
2021 4345 4345
2022 5113 5113
2023 6980 6980
2024 7318 7319
2025 1928 1928

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 2835 2835
Gas/Air Leak 2163 2163
Leak/Splash 1766 1766
Inability to Auto-Fill 1615 1615
Optical Problem 1289 1289
Break 1215 1215
Battery Problem 1201 1201
Failure to Sense 940 940
Incorrect, Inadequate or Imprecise Result or Readings 915 915
Display or Visual Feedback Problem 893 893
Unexpected Shutdown 852 852
Inflation Problem 790 790
Failure to Power Up 784 784
Pressure Problem 693 693
Failure to Charge 653 653
Device Displays Incorrect Message 612 612
Difficult to Insert 571 571
Erratic or Intermittent Display 562 562
Overheating of Device 556 556
No Display/Image 547 547
Device Contamination with Body Fluid 543 543
Premature Discharge of Battery 474 474
Device Alarm System 449 449
Fluid/Blood Leak 440 440
Noise, Audible 409 409
Power Problem 396 396
Connection Problem 311 311
Calibration Problem 305 305
Material Deformation 295 295
Electrical /Electronic Property Problem 292 292
Pumping Stopped 269 269
Inappropriate Waveform 261 261
Communication or Transmission Problem 253 253
Material Integrity Problem 243 243
Output Problem 240 240
Charging Problem 204 204
Retraction Problem 185 185
Material Rupture 178 178
Mechanical Problem 174 174
Difficult to Advance 168 168
No Apparent Adverse Event 167 167
No Device Output 162 162
Device Contamination with Chemical or Other Material 157 157
Decrease in Suction 143 143
Failure to Zero 139 139
Failure to Calibrate 139 139
Backflow 139 139
Restricted Flow rate 126 126
Mechanical Jam 106 106
Inadequate User Interface 105 105

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23224 23225
Insufficient Information 4187 4187
No Consequences Or Impact To Patient 1837 1837
No Patient Involvement 1656 1656
No Known Impact Or Consequence To Patient 519 519
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 306 306
Death 101 101
Low Blood Pressure/ Hypotension 65 65
Cardiac Arrest 59 59
Needle Stick/Puncture 47 47
No Information 41 41
Hemorrhage/Bleeding 31 31
Failure of Implant 27 27
Injury 26 26
Tachycardia 24 24
Myocardial Infarction 19 19
Cardiogenic Shock 19 19
Pain 15 15
Chest Pain 15 15
Vascular Dissection 14 14
Abdominal Pain 13 13
Stroke/CVA 13 13
Thrombosis/Thrombus 12 12
Foreign Body In Patient 12 12
Arrhythmia 11 11
Hematoma 11 11
Ischemia 10 10
Diminished Pulse Pressure 10 10
Bradycardia 9 9
Ventricular Fibrillation 9 9
Heart Failure/Congestive Heart Failure 8 8
Low Cardiac Output 8 8
Air Embolism 8 8
Pseudoaneurysm 7 7
Dyspnea 6 6
High Blood Pressure/ Hypertension 6 6
Perforation 6 6
Fever 5 5
Calcium Deposits/Calcification 5 5
Cardiac Tamponade 5 5
Shock 5 5
Unspecified Vascular Problem 5 5
Nausea 5 5
Atrial Fibrillation 4 4
Thromboembolism 4 4
Confusion/ Disorientation 4 4
Thrombus 4 4
Low Oxygen Saturation 4 4
Unspecified Heart Problem 3 3
Cardiovascular Insufficiency 3 3

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 Datascope Corp. II Nov-05-2024
5 Datascope Corp. I Sep-20-2024
6 Datascope Corp. I Sep-20-2024
7 Datascope Corp. II Aug-31-2023
8 Datascope Corp. I Aug-30-2023
9 Datascope Corp. I Aug-30-2023
10 Datascope Corp. I Aug-30-2023
11 Datascope Corp. I Aug-30-2023
12 Datascope Corp. II Jul-21-2023
13 Datascope Corp. I Jul-20-2023
14 Datascope Corp. I Jul-19-2023
15 Datascope Corp. III Jun-14-2023
16 Datascope Corp. II Apr-26-2023
17 Datascope Corp. II Mar-22-2023
18 Datascope Corp. I Mar-09-2023
19 Datascope Corp. I Mar-09-2023
20 Datascope Corp. II Mar-06-2023
21 Datascope Corp. II Mar-06-2023
22 Datascope Corp. I Jan-19-2023
23 Datascope Corp. I Dec-30-2021
24 Datascope Corp. I Oct-20-2021
25 Datascope Corp. II Oct-07-2021
26 Datascope Corp. II Sep-30-2021
27 Datascope Corp. III Apr-28-2021
28 Datascope Corporation II Sep-08-2022
29 Datascope Corporation II Aug-21-2020
30 Datascope Corporation II Feb-02-2020
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