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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
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 4
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
1 3 7 3 1 0

MDR Year MDR Reports MDR Events
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 1360 1360
Material Twisted/Bent 519 519
Material Deformation 271 271
Patient Device Interaction Problem 265 265
Entrapment of Device 153 153
Material Integrity Problem 147 147
Difficult to Remove 81 81
Fracture 74 74
Signal Artifact/Noise 74 74
Detachment of Device or Device Component 60 60
Material Separation 56 56
Material Frayed 44 44
Communication or Transmission Problem 42 42
Compatibility Problem 39 39
Mechanical Problem 38 38
Fluid/Blood Leak 34 34
Contamination /Decontamination Problem 34 34
Break 32 32
Activation, Positioning or Separation Problem 31 31
Mechanical Jam 27 27
Material Protrusion/Extrusion 25 25
Defective Device 25 25
Display or Visual Feedback Problem 23 23
Material Perforation 22 22
Device-Device Incompatibility 22 22
Device Contamination with Chemical or Other Material 21 21
Positioning Problem 21 21
Leak/Splash 20 20
Difficult to Insert 19 19
Insufficient Information 19 19
Improper Flow or Infusion 16 16
Delivered as Unsterile Product 16 16
Tear, Rip or Hole in Device Packaging 16 16
Coagulation in Device or Device Ingredient 14 14
Material Split, Cut or Torn 14 14
Appropriate Term/Code Not Available 12 12
Material Puncture/Hole 12 12
Device Contamination with Body Fluid 12 12
Use of Device Problem 11 11
Contamination 11 11
Component Misassembled 11 11
Poor Quality Image 10 10
Obstruction of Flow 10 10
Device Displays Incorrect Message 9 9
Failure to Sense 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Data Problem 7 7
Output Problem 7 7
Packaging Problem 7 7
Device Handling Problem 6 6
Electrical Shorting 6 6
Insufficient Cooling 6 6
Failure to Capture 6 6
Improper or Incorrect Procedure or Method 5 5
Failure to Unfold or Unwrap 5 5
Connection Problem 5 5
Protective Measures Problem 5 5
Mechanics Altered 5 5
Sharp Edges 5 5
Separation Problem 4 4
Air/Gas in Device 4 4
Physical Resistance/Sticking 4 4
Device Sensing Problem 4 4
Device Dislodged or Dislocated 4 4
High Readings 4 4
Material Rupture 4 4
Electrical /Electronic Property Problem 4 4
Loss of or Failure to Bond 3 3
No Display/Image 3 3
Difficult to Flush 3 3
Unable to Obtain Readings 3 3
Structural Problem 3 3
Failure to Advance 3 3
No Apparent Adverse Event 3 3
Therapeutic or Diagnostic Output Failure 3 3
Device Contaminated During Manufacture or Shipping 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Noise, Audible 2 2
Expiration Date Error 2 2
Incorrect, Inadequate or Imprecise Result or Readings 2 2
Self-Activation or Keying 2 2
Failure to Analyze Signal 2 2
Material Too Rigid or Stiff 2 2
High impedance 2 2
Image Display Error/Artifact 2 2
No Device Output 2 2
Pacing Problem 2 2
Unsealed Device Packaging 2 2
Peeled/Delaminated 2 2
Product Quality Problem 1 1
Overheating of Device 1 1
Inflation Problem 1 1
Thermal Decomposition of Device 1 1
Intermittent Capture 1 1
Device Alarm System 1 1
Crack 1 1
Degraded 1 1
Unintended Power Up 1 1
Failure to Discharge 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1135 1135
Cardiac Tamponade 488 488
Cardiac Perforation 426 426
Pericardial Effusion 377 377
No Consequences Or Impact To Patient 359 359
Low Blood Pressure/ Hypotension 227 227
No Known Impact Or Consequence To Patient 173 173
Stroke/CVA 123 123
Hematoma 63 63
Death 57 57
Heart Block 55 55
Fistula 54 54
Hemorrhage/Bleeding 50 50
Cardiac Arrest 44 44
Pseudoaneurysm 44 44
Chest Pain 41 41
Insufficient Information 38 38
Arrhythmia 34 34
Transient Ischemic Attack 33 33
Thrombosis/Thrombus 32 32
Vascular Dissection 32 32
No Code Available 32 32
Tachycardia 30 30
Air Embolism 22 22
Non specific EKG/ECG Changes 21 21
Paralysis 20 20
Perforation 20 20
Inflammation 19 19
Hemoptysis 19 19
Unspecified Tissue Injury 19 19
Foreign Body In Patient 18 18
Dyspnea 17 17
Ischemia Stroke 16 16
No Patient Involvement 15 15
Bradycardia 14 14
Nerve Damage 14 14
Embolism/Embolus 14 14
Pericarditis 13 13
Tissue Damage 13 13
Atrial Fibrillation 12 12
Perforation of Vessels 11 11
Rupture 11 11
Physical Entrapment 10 10
Great Vessel Perforation 10 10
Myocardial Infarction 10 10
Mitral Valve Insufficiency/ Regurgitation 10 10
Heart Failure/Congestive Heart Failure 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Embolism 9 9
Fever 9 9
Heart Failure 9 9
Vascular System (Circulation), Impaired 9 9
Complete Heart Block 8 8
Ventricular Fibrillation 8 8
Atrial Flutter 8 8
Pulmonary Edema 8 8
Sepsis 8 8
ST Segment Elevation 7 7
Pulmonary Valve Stenosis 7 7
Pneumonia 7 7
Thrombosis 7 7
Stenosis 7 7
Respiratory Failure 7 7
Vasoconstriction 6 6
Thrombus 6 6
Pleural Effusion 6 6
Device Embedded In Tissue or Plaque 6 6
Vaso-Vagal Response 5 5
Retroperitoneal Hemorrhage 5 5
Pneumothorax 5 5
Nausea 5 5
High Blood Pressure/ Hypertension 5 5
Unspecified Infection 5 5
Intracranial Hemorrhage 5 5
Cardiomyopathy 5 5
Muscle Weakness 5 5
Ventricular Tachycardia 5 5
Dizziness 5 5
Cardiogenic Shock 5 5
Loss of consciousness 5 5
Blood Loss 5 5
Diminished Pulse Pressure 5 5
Confusion/ Disorientation 4 4
Weakness 4 4
Visual Disturbances 4 4
Cardiopulmonary Arrest 4 4
Pulmonary Embolism 4 4
Hypoxia 4 4
Paresis 4 4
Unspecified Heart Problem 4 4
Syncope/Fainting 4 4
Foreign Body Embolism 3 3
Neurological Deficit/Dysfunction 3 3
Pain 3 3
Renal Failure 3 3
Hemothorax 3 3
Abdominal Pain 3 3
Discomfort 3 3
Thromboembolism 3 3
Coma 3 3

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