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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, intracardiac mapping, high-density array
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeMTD
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABLACON, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 3
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 1
STERILMED INC. (JOHNSON AND JOHNSON)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 87 87
2021 99 99
2022 145 145
2023 184 184
2024 379 379
2025 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 262 262
Obstruction of Flow 187 187
Entrapment of Device 80 80
Device Contamination with Body Fluid 80 80
Detachment of Device or Device Component 69 69
Contamination /Decontamination Problem 64 64
Signal Artifact/Noise 63 63
Adverse Event Without Identified Device or Use Problem 61 61
Material Twisted/Bent 55 55
Device-Device Incompatibility 45 45
Material Protrusion/Extrusion 39 39
Coagulation in Device or Device Ingredient 39 39
Break 29 29
Display or Visual Feedback Problem 25 25
Material Separation 19 19
Complete Blockage 18 18
Sharp Edges 18 18
Material Deformation 16 16
Tear, Rip or Hole in Device Packaging 15 15
Mechanical Jam 15 15
Communication or Transmission Problem 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Positioning Problem 12 12
Improper or Incorrect Procedure or Method 9 9
Packaging Problem 8 8
Off-Label Use 7 7
Delivered as Unsterile Product 6 6
Failure to Sense 5 5
Appropriate Term/Code Not Available 5 5
Application Program Problem 5 5
Electrical Shorting 4 4
Separation Problem 4 4
Failure to Advance 4 4
Contamination 3 3
Therapeutic or Diagnostic Output Failure 3 3
Partial Blockage 3 3
Material Too Rigid or Stiff 2 2
Material Integrity Problem 2 2
Insufficient Information 2 2
Device Sensing Problem 2 2
Fluid/Blood Leak 1 1
Protective Measures Problem 1 1
Failure to Unfold or Unwrap 1 1
Device Emits Odor 1 1
Electromagnetic Compatibility Problem 1 1
Component Missing 1 1
Use of Device Problem 1 1
Device Alarm System 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 606 606
Cardiac Tamponade 124 124
Foreign Body In Patient 61 61
No Consequences Or Impact To Patient 35 35
Cardiac Arrest 24 24
Cardiac Perforation 17 17
Stroke/CVA 16 16
Ischemic Heart Disease 15 15
Air Embolism 14 14
No Code Available 12 12
Thrombosis/Thrombus 11 11
Low Blood Pressure/ Hypotension 9 9
Pericardial Effusion 9 9
Heart Block 8 8
Unspecified Tissue Injury 6 6
Insufficient Information 6 6
Ventricular Fibrillation 6 6
Transient Ischemic Attack 5 5
Rupture 5 5
No Known Impact Or Consequence To Patient 4 4
Tachycardia 4 4
Perforation of Vessels 4 4
Hematoma 3 3
Pseudoaneurysm 3 3
Death 3 3
Arrhythmia 3 3
Pericarditis 2 2
Paralysis 2 2
Vasoconstriction 2 2
Ventricular Tachycardia 2 2
Thrombosis 2 2
Cardiogenic Shock 2 2
Bradycardia 2 2
Pneumothorax 2 2
Myocardial Infarction 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Failure 2 2
Urinary Tract Infection 2 2
Cognitive Changes 1 1
Anemia 1 1
Unspecified Nervous System Problem 1 1
Perforation 1 1
Respiratory Arrest 1 1
Nerve Damage 1 1
Pleural Effusion 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Visual Impairment 1 1
Asystole 1 1
Heart Failure/Congestive Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott II Jun-01-2022
2 BIOSENSE WEBSTER II Jun-16-2020
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