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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, electrode recording, or probe, electrode recording
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACCESS POINT TECHNOLOGIES EP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
CATHRXLTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 6
MEDFACT ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021 2022 2023 2024
2 6 1 1 3 7 3 1 0

MDR Year MDR Reports MDR Events
2016 383 383
2017 458 458
2018 723 723
2019 669 669
2020 651 651
2021 625 625
2022 613 613
2023 686 686
2024 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2085 2085
Material Twisted/Bent 577 577
Material Deformation 317 317
Patient Device Interaction Problem 265 265
Entrapment of Device 199 199
Material Integrity Problem 166 166
Difficult to Remove 114 114
Appropriate Term/Code Not Available 111 111
Fracture 90 90
Signal Artifact/Noise 86 86
Insufficient Information 82 82
Break 75 75
Material Separation 74 74
Kinked 69 69
Detachment of Device or Device Component 67 67
Communication or Transmission Problem 50 50
Material Frayed 49 49
Fluid/Blood Leak 45 45
Device Operates Differently Than Expected 44 44
Mechanical Problem 42 42
Device Contamination with Chemical or Other Material 39 39
Compatibility Problem 39 39
Mechanical Jam 38 38
Contamination /Decontamination Problem 37 37
Activation, Positioning or Separation Problem 34 34
Positioning Problem 33 33
Material Protrusion/Extrusion 30 30
Device Sensing Problem 28 28
Defective Device 28 28
Display or Visual Feedback Problem 26 26
Detachment Of Device Component 24 24
Leak/Splash 23 23
Failure to Sense 23 23
Material Perforation 22 22
Device-Device Incompatibility 22 22
Improper Flow or Infusion 22 22
Device Displays Incorrect Message 22 22
Difficult to Insert 22 22
Delivered as Unsterile Product 20 20
Material Split, Cut or Torn 20 20
Tear, Rip or Hole in Device Packaging 18 18
Use of Device Problem 15 15
Contamination 15 15
Failure to Capture 15 15
Coagulation in Device or Device Ingredient 15 15
Noise, Audible 15 15
Material Puncture/Hole 14 14
Sticking 13 13
Device Contamination with Body Fluid 12 12
Improper or Incorrect Procedure or Method 11 11
Poor Quality Image 11 11
Device Dislodged or Dislocated 11 11
Knotted 11 11
Output Problem 11 11
Component Misassembled 11 11
Packaging Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Obstruction of Flow 10 10
Failure to Unfold or Unwrap 8 8
Connection Problem 8 8
Electrical /Electronic Property Problem 8 8
Bent 8 8
Device Handling Problem 8 8
Sharp Edges 8 8
No Apparent Adverse Event 7 7
Data Problem 7 7
No Display/Image 7 7
Hole In Material 7 7
Device Issue 7 7
Expiration Date Error 6 6
Defective Component 6 6
Electrical Shorting 6 6
Difficult to Advance 6 6
High impedance 6 6
Pacing Problem 6 6
Insufficient Cooling 6 6
Temperature Problem 6 6
Protective Measures Problem 5 5
Mechanics Altered 5 5
Separation Problem 5 5
Physical Resistance/Sticking 5 5
Air Leak 5 5
Device Alarm System 5 5
Unsealed Device Packaging 5 5
Material Rupture 5 5
Device Damaged by Another Device 5 5
Device Packaging Compromised 5 5
Physical Resistance 5 5
Failure to Advance 5 5
High Readings 4 4
Structural Problem 4 4
Device Damaged Prior to Use 4 4
Device Inoperable 4 4
Difficult to Open or Remove Packaging Material 4 4
Device Operational Issue 4 4
Malposition of Device 4 4
Unable to Obtain Readings 4 4
Crack 4 4
Air/Gas in Device 4 4
Scratched Material 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1135 1135
Cardiac Tamponade 719 719
Cardiac Perforation 700 700
No Consequences Or Impact To Patient 661 661
Pericardial Effusion 553 553
No Known Impact Or Consequence To Patient 430 430
Low Blood Pressure/ Hypotension 345 345
Stroke/CVA 151 151
Death 113 113
Hematoma 96 98
Fistula 90 92
No Code Available 84 84
Cardiac Arrest 69 69
Pseudoaneurysm 64 64
Hemorrhage/Bleeding 62 62
Chest Pain 55 55
Heart Block 55 55
Arrhythmia 53 53
Vascular Dissection 52 52
No Patient Involvement 48 48
Transient Ischemic Attack 39 39
Tachycardia 38 38
Insufficient Information 38 38
Air Embolism 36 36
Perforation 34 34
Thrombosis/Thrombus 32 32
Tissue Damage 30 30
Hemoptysis 30 30
Paralysis 26 26
ST Segment Elevation 24 24
Dyspnea 23 23
Complete Heart Block 23 23
Foreign Body In Patient 21 21
Non specific EKG/ECG Changes 21 21
Bradycardia 20 20
Inflammation 20 20
Nerve Damage 19 19
Atrial Fibrillation 19 19
Blood Loss 19 19
Unspecified Tissue Injury 19 19
Thrombus 18 18
Vascular System (Circulation), Impaired 17 17
Ischemia Stroke 16 16
Thrombosis 15 15
Perforation of Vessels 15 15
Rupture 15 15
Embolism 15 15
Fever 15 15
Physical Entrapment 14 14
Embolism/Embolus 14 14
Pericarditis 13 13
Vaso-Vagal Response 13 13
Great Vessel Perforation 13 13
Ventricular Fibrillation 13 13
Ventricular Tachycardia 13 13
Sepsis 13 13
Myocardial Infarction 13 13
Pleural Effusion 12 12
Pneumothorax 12 12
Heart Failure 12 12
Device Embedded In Tissue or Plaque 12 12
Partial thickness (Second Degree) Burn 11 11
Pneumonia 11 11
Cardiopulmonary Arrest 11 11
No Information 10 10
Mitral Valve Insufficiency/ Regurgitation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Heart Failure/Congestive Heart Failure 10 10
Atrial Flutter 9 9
Pain 9 9
Vasoconstriction 9 9
Cardiogenic Shock 9 9
Stenosis 8 8
Injury 8 8
Pulmonary Edema 8 8
Respiratory Failure 8 8
Diminished Pulse Pressure 7 7
Pulmonary Valve Stenosis 7 7
Paresis 7 7
Loss of consciousness 7 7
Dizziness 7 7
Pulmonary Embolism 7 7
Unspecified Infection 7 7
Nausea 6 6
High Blood Pressure/ Hypertension 6 6
Intracranial Hemorrhage 6 6
Hemothorax 6 6
Laceration(s) of Esophagus 6 6
Not Applicable 6 6
Thromboembolism 5 5
Aortic Dissection 5 5
Retroperitoneal Hemorrhage 5 5
Weakness 5 5
Discomfort 5 5
Complaint, Ill-Defined 5 5
Muscle Weakness 5 5
Neurological Deficit/Dysfunction 5 5
Hypoxia 5 5
Cardiomyopathy 5 5
Infarction, Cerebral 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Sep-19-2018
2 Irvine Biomedical Inc, a St. Jude Medical Co. II Sep-24-2020
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