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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, INC.
  SUBSTANTIALLY EQUIVALENT 2
  1.  K190101  UltraFlex IAB
  2.  K190117  Fiberoptix IAB
ARROW INTERNATIONAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 3394
2021 4345 4346
2022 5113 5120
2023 6980 6981
2024 7318 7319
2025 6109 6109

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 3469 3469
Gas/Air Leak 3230 3230
Leak/Splash 2291 2291
Inability to Auto-Fill 2090 2090
Battery Problem 1654 1654
Break 1603 1603
Display or Visual Feedback Problem 1517 1517
Optical Problem 1418 1418
Device Displays Incorrect Message 1396 1396
Failure to Sense 1177 1177
Inflation Problem 1110 1110
Unexpected Shutdown 1108 1108
Failure to Power Up 1098 1098
Incorrect, Inadequate or Imprecise Result or Readings 1081 1081
Device Alarm System 899 899
Pressure Problem 869 869
Fluid/Blood Leak 799 799
No Display/Image 785 785
Difficult to Insert 767 767
Failure to Charge 761 761
Overheating of Device 742 742
Device Contamination with Body Fluid 684 684
Erratic or Intermittent Display 654 654
Premature Discharge of Battery 612 612
Noise, Audible 586 586
Electrical /Electronic Property Problem 545 545
Power Problem 500 500
Material Rupture 461 462
Pumping Stopped 427 427
Calibration Problem 421 421
Connection Problem 414 414
Material Deformation 413 413
Charging Problem 412 412
Device Contamination with Chemical or Other Material 394 394
Communication or Transmission Problem 354 354
Output Problem 338 338
No Device Output 307 307
Material Integrity Problem 291 291
Difficult to Advance 288 288
Inappropriate Waveform 279 279
Mechanical Problem 256 256
Failure to Calibrate 231 231
Device Operates Differently Than Expected 229 229
Failure to Read Input Signal 205 205
Loss of Power 205 205
Moisture or Humidity Problem 204 204
Retraction Problem 203 203
Failure to Zero 195 195
No Apparent Adverse Event 189 189
Backflow 175 175

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 27355 27357
Insufficient Information 4614 4620
No Patient Involvement 3899 3899
No Consequences Or Impact To Patient 3716 3716
No Known Impact Or Consequence To Patient 3111 3112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 309 309
Death 251 251
Low Blood Pressure/ Hypotension 114 114
Cardiac Arrest 76 76
Injury 70 70
Needle Stick/Puncture 58 58
No Information 51 51
Hemorrhage/Bleeding 50 50
Myocardial Infarction 50 50
Calcium Deposits/Calcification 40 41
Cardiogenic Shock 36 36
Failure of Implant 35 36
Tachycardia 30 30
Chest Pain 26 26
No Code Available 24 25
Blood Loss 23 23
Pain 20 20
Abdominal Pain 18 18
Ischemia 17 17
Nausea 17 17
Vascular Dissection 16 16
Stroke/CVA 15 15
Thrombus 14 14
Ventricular Fibrillation 14 14
Arrhythmia 14 14
Thrombosis/Thrombus 14 14
Hematoma 13 13
Foreign Body In Patient 13 13
Low Cardiac Output 12 12
Heart Failure/Congestive Heart Failure 12 12
Diminished Pulse Pressure 11 11
Device Embedded In Tissue or Plaque 11 11
Rupture 11 11
Bradycardia 10 10
Vomiting 10 10
Air Embolism 10 10
Atrial Fibrillation 10 10
Pseudoaneurysm 9 9
High Blood Pressure/ Hypertension 9 9
Dyspnea 8 8
Loss of consciousness 8 8
Perforation 7 7
Cardiac Tamponade 7 7
Vessel Or Plaque, Device Embedded In 7 7
Hypoxia 6 6

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 Corp. I Jul-16-2019
29 Datascope Corporation II Sep-08-2022
30 Datascope Corporation II Aug-21-2020
31 Datascope Corporation II Feb-02-2020
32 Datascope Corporation II Jul-12-2019
33 Datascope Corporation II Oct-11-2018
34 Datascope Corporation II Apr-16-2018
35 Insightra Medical Inc II Aug-13-2025
36 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
37 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
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