Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, balloon, intra-aortic and control
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
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 6978 6978
2024 1749 1749

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 2497 2497
Appropriate Term/Code Not Available 2327 2327
Gas/Air Leak 2143 2143
Leak/Splash 1871 1871
Inability to Auto-Fill 1474 1474
Break 1237 1237
Battery Problem 1194 1194
Optical Problem 1124 1124
Device Operates Differently Than Expected 985 985
Failure to Sense 958 958
Display or Visual Feedback Problem 958 958
Fluid/Blood Leak 854 854
Incorrect, Inadequate or Imprecise Result or Readings 842 842
Device Alarm System 818 818
Failure to Power Up 791 791
No Display/Image 787 787
Unexpected Shutdown 776 776
Inflation Problem 765 765
Pressure Problem 749 749
Difficult to Insert 704 704
Failure to Charge 643 643
Erratic or Intermittent Display 542 542
Device Contamination with Body Fluid 541 541
Material Rupture 540 540
Premature Discharge of Battery 531 531
Noise, Audible 469 469
Pumping Stopped 459 459
Device Contamination with Chemical or Other Material 417 417
Overheating of Device 377 377
Power Problem 373 373
Loss of Power 353 353
Calibration Problem 338 338
Connection Problem 318 318
Communication or Transmission Problem 317 317
Material Deformation 311 311
Charging Problem 290 290
Difficult to Advance 257 257
Moisture or Humidity Problem 253 253
Electrical /Electronic Property Problem 242 242
Inappropriate Waveform 234 234
Adverse Event Without Identified Device or Use Problem 222 222
Output Problem 200 200
Failure to Calibrate 199 199
Failure to Advance 197 197
Backflow 194 194
Failure to Zero 193 193
Moisture Damage 189 189
Mechanical Problem 174 174
Retraction Problem 168 168
No Apparent Adverse Event 168 168
Difficult to Remove 161 161
Filling Problem 148 148
Device Inoperable 136 136
Material Integrity Problem 130 130
Defective Component 123 123
Unraveled Material 119 119
No Device Output 118 118
Unable to Obtain Readings 107 107
Decrease in Suction 102 102
Loose or Intermittent Connection 99 99
Device Damaged Prior to Use 97 97
Image Display Error/Artifact 95 95
Device Sensing Problem 92 92
Circuit Failure 91 91
Inadequate User Interface 86 86
Insufficient Information 84 84
Restricted Flow rate 83 83
Failure to Pump 81 81
Obstruction of Flow 79 79
Difficult to Flush 79 79
Crack 78 78
Kinked 76 76
Component Missing 76 76
Therapeutic or Diagnostic Output Failure 76 76
Incomplete or Inadequate Connection 75 75
Defective Device 75 75
Output below Specifications 74 74
Failure of Device to Self-Test 70 70
Material Twisted/Bent 69 69
Failure to Run on Battery 69 69
Failure to Read Input Signal 68 68
Mechanical Jam 67 67
Migration 66 66
Off-Label Use 65 65
Material Puncture/Hole 62 62
Device Emits Odor 62 62
Use of Device Problem 61 61
Temperature Problem 59 59
Infusion or Flow Problem 59 59
Deformation Due to Compressive Stress 57 57
Gas Output Problem 57 57
Component Incompatible 54 54
Disconnection 54 54
Occlusion Within Device 52 52
Protective Measures Problem 50 50
Audible Prompt/Feedback Problem 50 50
Device Markings/Labelling Problem 48 48
Detachment of Device or Device Component 47 47
Complete Loss of Power 47 47
Suction Problem 46 46

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16430 16430
No Consequences Or Impact To Patient 5021 5021
No Patient Involvement 4822 4822
No Known Impact Or Consequence To Patient 4544 4544
Insufficient Information 2958 2958
Death 767 767
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 253 253
Myocardial Infarction 174 174
Low Blood Pressure/ Hypotension 131 131
Cardiogenic Shock 123 123
No Information 112 112
Cardiac Arrest 89 89
Injury 83 83
Hemorrhage/Bleeding 78 78
Calcium Deposits/Calcification 68 69
Complaint, Ill-Defined 61 61
Needle Stick/Puncture 55 55
Blood Loss 51 51
No Code Available 49 50
Chest Pain 39 39
Failure of Implant 25 25
Ischemia 25 25
Tachycardia 25 25
Thrombus 24 24
High Blood Pressure/ Hypertension 24 24
Hematoma 21 21
Pain 20 20
Stroke/CVA 19 19
Abdominal Pain 18 18
Ventricular Fibrillation 18 18
Angina 16 16
Atherosclerosis 16 16
Arrhythmia 15 15
Cardiopulmonary Arrest 15 15
Nausea 15 15
Vascular Dissection 15 15
Low Cardiac Output 15 15
Atrial Fibrillation 14 14
Bradycardia 14 14
Congestive Heart Failure 14 14
Heart Failure 14 14
Device Embedded In Tissue or Plaque 13 13
Ischemic Heart Disease 12 12
Foreign Body In Patient 12 12
Rupture 12 12
Renal Failure 12 12
Diminished Pulse Pressure 11 11
Pseudoaneurysm 10 10
Pulmonary Edema 10 10
Shock 10 10
Loss of consciousness 10 10
Air Embolism 10 10
Vessel Or Plaque, Device Embedded In 10 10
Thrombosis/Thrombus 9 9
Dyspnea 8 8
Cardiac Tamponade 8 8
Venipuncture 8 8
Ventricular Tachycardia 7 7
Perforation of Vessels 7 7
Vomiting 7 7
Fever 7 7
Cardiomyopathy 7 7
Perforation 7 7
Hypoxia 7 7
Peripheral Vascular Disease 6 6
Unspecified Infection 6 6
Brain Injury 6 6
Chest Tightness/Pressure 6 6
Low Oxygen Saturation 6 6
Aortic Dissection 6 6
Vascular System (Circulation), Impaired 6 6
Patient Problem/Medical Problem 6 6
Loss Of Pulse 5 5
Unspecified Vascular Problem 5 5
Heart Failure/Congestive Heart Failure 5 5
ST Segment Elevation 5 5
Surgical procedure, repeated 5 5
Paresis 5 5
Left Ventricular Dysfunction 5 5
Mitral Regurgitation 5 5
Aneurysm 5 5
Non specific EKG/ECG Changes 5 5
Bone Fracture(s) 4 4
Pulmonary Embolism 4 4
Arteriosclerosis 4 4
Aortic Valve Stenosis 4 4
Mitral Insufficiency 4 4
Occlusion 4 4
Respiratory Distress 4 4
Discomfort 4 4
Respiratory Failure 4 4
Obstruction/Occlusion 4 4
Thromboembolism 4 4
Confusion/ Disorientation 4 4
Cognitive Changes 3 3
Test Result 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Unspecified Kidney or Urinary Problem 3 3
Numbness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 ARROW INTERNATIONAL Inc. I Dec-15-2022
2 Arrow International Inc I Jun-26-2020
3 Arrow International Inc II Mar-10-2015
4 Arrow International Inc II Mar-02-2015
5 Arrow International Inc II Apr-06-2013
6 Arrow International, Inc. I Apr-16-2009
7 Arrow International, Inc., Division of Teleflex Medical Inc. I Mar-11-2016
8 Arrow International, Inc., Division of Teleflex Medical Inc. I Dec-23-2010
9 Datascope Corp. II Aug-31-2023
10 Datascope Corp. I Aug-30-2023
11 Datascope Corp. I Aug-30-2023
12 Datascope Corp. I Aug-30-2023
13 Datascope Corp. I Aug-30-2023
14 Datascope Corp. II Jul-21-2023
15 Datascope Corp. I Jul-20-2023
16 Datascope Corp. I Jul-19-2023
17 Datascope Corp. III Jun-14-2023
18 Datascope Corp. II Apr-26-2023
19 Datascope Corp. II Mar-22-2023
20 Datascope Corp. I Mar-09-2023
21 Datascope Corp. I Mar-09-2023
22 Datascope Corp. II Mar-06-2023
23 Datascope Corp. II Mar-06-2023
24 Datascope Corp. I Jan-19-2023
25 Datascope Corp. I Dec-30-2021
26 Datascope Corp. I Oct-20-2021
27 Datascope Corp. II Oct-07-2021
28 Datascope Corp. II Sep-30-2021
29 Datascope Corp. III Apr-28-2021
30 Datascope Corp. I Jul-16-2019
31 Datascope Corporation II Sep-08-2022
32 Datascope Corporation II Aug-21-2020
33 Datascope Corporation II Feb-02-2020
34 Datascope Corporation II Jul-12-2019
35 Datascope Corporation II Oct-11-2018
36 Datascope Corporation II Apr-16-2018
37 Datascope Corporation II Jun-08-2016
38 Datascope Corporation III Sep-03-2014
39 Datascope Corporation II Jun-21-2010
40 Datascope Corporation II Apr-15-2009
41 Maquet Cardiovascular, LLC II Jan-09-2013
42 Maquet Datascope Corp - Cardiac Assist Division I Oct-27-2018
43 Maquet Datascope Corp - Cardiac Assist Division I May-31-2018
44 Maquet Datascope Corp - Cardiac Assist Division I Sep-05-2017
45 Maquet Datascope Corp - Cardiac Assist Division I Jun-23-2017
46 Maquet Datascope Corp - Cardiac Assist Division II Mar-02-2017
47 Maquet Datascope Corp - Cardiac Assist Division II Mar-25-2016
48 Maquet Datascope Corp - Cardiac Assist Division II Feb-23-2015
49 Maquet Datascope Corp - Cardiac Assist Division II Feb-07-2015
50 Maquet Datascope Corp - Cardiac Assist Division I May-21-2014
-
-