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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
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
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 536 536

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 2091 2091
Gas/Air Leak 1811 1811
Leak/Splash 1469 1469
Inability to Auto-Fill 1233 1233
Optical Problem 1076 1076
Break 994 994
Battery Problem 921 921
Failure to Sense 866 866
Display or Visual Feedback Problem 779 779
Incorrect, Inadequate or Imprecise Result or Readings 755 755
Unexpected Shutdown 724 724
Pressure Problem 657 657
Device Displays Incorrect Message 644 644
Failure to Power Up 618 618
Failure to Charge 522 522
Difficult to Insert 521 521
Inflation Problem 515 515
No Display/Image 507 507
Erratic or Intermittent Display 488 488
Premature Discharge of Battery 483 483
Device Contamination with Body Fluid 433 433
Fluid/Blood Leak 420 420
Device Contamination with Chemical or Other Material 367 367
Noise, Audible 333 333
Overheating of Device 326 326
Power Problem 315 315
Pumping Stopped 313 313
Material Deformation 274 274
Device Alarm System 273 273
Calibration Problem 272 272
Connection Problem 242 242
Inappropriate Waveform 229 229
Communication or Transmission Problem 221 221
Charging Problem 216 216
Material Rupture 212 212
Electrical /Electronic Property Problem 198 198
Difficult to Advance 187 187
Output Problem 183 183
No Apparent Adverse Event 151 151
Retraction Problem 150 150
Moisture or Humidity Problem 146 146
Failure to Zero 143 143
Backflow 143 143
Mechanical Problem 137 137
Adverse Event Without Identified Device or Use Problem 129 129
Failure to Calibrate 123 123
Filling Problem 122 122
Material Integrity Problem 100 100
Difficult to Remove 96 96
No Device Output 93 93
Unraveled Material 91 91
Circuit Failure 78 78
Restricted Flow rate 77 77
Therapeutic or Diagnostic Output Failure 75 75
Loss of Power 74 74
Decrease in Suction 73 73
Incomplete or Inadequate Connection 73 73
Output below Specifications 69 69
Difficult to Flush 68 68
Defective Component 66 66
Failure to Advance 64 64
Obstruction of Flow 62 62
Inadequate User Interface 62 62
Off-Label Use 62 62
Loose or Intermittent Connection 62 62
Material Twisted/Bent 60 60
Migration 59 59
Unable to Obtain Readings 58 58
Infusion or Flow Problem 56 56
Mechanical Jam 55 55
Failure to Run on Battery 55 55
Component Incompatible 53 53
Gas Output Problem 51 51
Temperature Problem 49 49
Image Display Error/Artifact 48 48
Crack 48 48
Failure to Pump 48 48
Audible Prompt/Feedback Problem 47 47
Use of Device Problem 46 46
Insufficient Information 46 46
Failure to Read Input Signal 45 45
Complete Loss of Power 45 45
Device Sensing Problem 44 44
Component Missing 41 41
Device Markings/Labelling Problem 40 40
Deformation Due to Compressive Stress 39 39
Protective Measures Problem 39 39
Defective Device 38 38
Material Puncture/Hole 38 38
Device Emits Odor 38 38
Detachment of Device or Device Component 35 35
Suction Problem 31 31
Deflation Problem 31 31
Application Program Freezes, Becomes Nonfunctional 30 30
Material Frayed 29 29
No Audible Alarm 29 29
Device Damaged Prior to Use 29 29
Device Handling Problem 28 28
Fracture 28 28
Incorrect Measurement 27 27

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15066 15066
No Consequences Or Impact To Patient 3208 3208
No Patient Involvement 3026 3026
Insufficient Information 2671 2671
No Known Impact Or Consequence To Patient 1366 1366
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 248 248
Death 169 169
Low Blood Pressure/ Hypotension 67 67
Injury 65 65
Needle Stick/Puncture 52 52
Cardiac Arrest 49 49
No Information 43 43
Hemorrhage/Bleeding 25 25
Tachycardia 20 20
Chest Pain 19 19
Cardiogenic Shock 18 18
Failure of Implant 18 18
Abdominal Pain 12 12
Myocardial Infarction 12 12
Pain 11 11
Calcium Deposits/Calcification 11 12
Thrombus 11 11
Arrhythmia 11 11
Diminished Pulse Pressure 11 11
Ischemia 10 10
Vascular Dissection 9 9
Stroke/CVA 9 9
Bradycardia 9 9
Ventricular Fibrillation 9 9
Air Embolism 8 8
Pseudoaneurysm 8 8
No Code Available 8 9
Thrombosis/Thrombus 8 8
Hematoma 7 7
Low Cardiac Output 7 7
Perforation 7 7
Atrial Fibrillation 7 7
Blood Loss 6 6
Device Embedded In Tissue or Plaque 6 6
Dyspnea 6 6
Foreign Body In Patient 6 6
Shock 5 5
Nausea 5 5
Heart Failure/Congestive Heart Failure 5 5
Low Oxygen Saturation 5 5
Fever 5 5
Unspecified Vascular Problem 5 5
Cardiac Tamponade 5 5
High Blood Pressure/ Hypertension 5 5
Ventricular Tachycardia 4 4
Paresis 3 3
Liver Laceration(s) 3 3
Confusion/ Disorientation 3 3
Perforation of Vessels 3 3
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Unspecified Kidney or Urinary Problem 3 3
Chest Tightness/Pressure 3 3
Vessel Or Plaque, Device Embedded In 3 3
Rupture 3 3
Pneumothorax 3 3
Mitral Valve Insufficiency/ Regurgitation 3 3
Dizziness 3 3
Loss of consciousness 3 3
Thromboembolism 3 3
Patient Problem/Medical Problem 3 3
Hypoxia 2 2
Swelling/ Edema 2 2
Bruise/Contusion 2 2
Great Vessel Perforation 2 2
Vomiting 2 2
Headache 2 2
Aneurysm 2 2
Irregular Pulse 2 2
Test Result 2 2
Laceration(s) 2 2
Emotional Changes 2 2
Extravasation 2 2
Non specific EKG/ECG Changes 2 2
Vascular System (Circulation), Impaired 2 2
Heart Failure 2 2
Unspecified Tissue Injury 2 2
Convulsion/Seizure 2 2
Embolism/Embolus 2 2
Pulmonary Embolism 2 2
Cardiomyopathy 2 2
Aortic Dissection 2 2
Ischemic Heart Disease 1 1
Physical Entrapment 1 1
Intracranial Hemorrhage 1 1
Renal Impairment 1 1
Cyanosis 1 1
Urinary Incontinence 1 1
Urinary Retention 1 1
Bone Fracture(s) 1 1
Unspecified Hepatic or Biliary Problem 1 1
Fecal Incontinence 1 1
Fatigue 1 1
Skin Discoloration 1 1
Cardiac Perforation 1 1
Dysphasia 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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