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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
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
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 7
CATHRXLTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
3 7 3 1 2 1

MDR Year MDR Reports MDR Events
2020 651 651
2021 625 625
2022 613 615
2023 685 686
2024 623 625
2025 473 473

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1234 1236
Material Twisted/Bent 614 615
Patient Device Interaction Problem 371 371
Material Deformation 274 274
Entrapment of Device 187 189
Material Integrity Problem 135 135
Fracture 113 113
Signal Artifact/Noise 105 105
Compatibility Problem 81 81
Difficult to Remove 76 76
Communication or Transmission Problem 68 68
Mechanical Problem 63 63
Detachment of Device or Device Component 59 59
Material Separation 57 58
Contamination /Decontamination Problem 47 47
Break 44 44
Activation, Positioning or Separation Problem 42 42
Display or Visual Feedback Problem 41 41
Fluid/Blood Leak 39 39
Material Frayed 38 38
Coagulation in Device or Device Ingredient 33 33
Mechanical Jam 31 31
Device Contamination with Body Fluid 31 31
Material Protrusion/Extrusion 31 31
Device-Device Incompatibility 29 29
Difficult to Insert 29 29
Material Perforation 27 27
Defective Device 25 25
Obstruction of Flow 24 24
Insufficient Information 24 24
Delivered as Unsterile Product 23 23
Leak/Splash 23 23
Device Contamination with Chemical or Other Material 22 22
Positioning Problem 22 22
Tear, Rip or Hole in Device Packaging 19 19
Improper or Incorrect Procedure or Method 19 19
Manufacturing, Packaging or Shipping Problem 18 18
Improper Flow or Infusion 18 18
Use of Device Problem 14 14
Failure to Sense 13 14
Appropriate Term/Code Not Available 13 13
Contamination 12 12
Component Misassembled 11 11
Material Puncture/Hole 11 11
Packaging Problem 11 11
Electrical Shorting 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Material Split, Cut or Torn 9 9
Output Problem 8 8
Connection Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1668 1670
Cardiac Tamponade 548 548
Pericardial Effusion 366 366
Cardiac Perforation 325 326
Low Blood Pressure/ Hypotension 222 222
No Consequences Or Impact To Patient 208 208
Stroke/CVA 124 124
Heart Block 79 79
Insufficient Information 65 65
Hemorrhage/Bleeding 62 62
Hematoma 59 59
Fistula 54 54
Cardiac Arrest 53 53
Pseudoaneurysm 51 51
No Known Impact Or Consequence To Patient 50 50
Arrhythmia 43 43
Thrombosis/Thrombus 41 41
Tachycardia 39 39
Chest Pain 37 37
Transient Ischemic Attack 35 35
Foreign Body In Patient 32 33
Unspecified Tissue Injury 30 30
Non specific EKG/ECG Changes 29 29
Death 28 28
Perforation 26 26
Air Embolism 24 24
Atrial Fibrillation 24 24
Hemoptysis 23 23
Vascular Dissection 23 23
Embolism/Embolus 21 22
Inflammation 20 20
Bradycardia 20 21
Ischemia Stroke 19 19
Paralysis 18 18
Pericarditis 18 18
Nerve Damage 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Myocardial Infarction 15 15
Atrial Flutter 15 15
Dyspnea 15 15
No Code Available 14 14
Heart Failure/Congestive Heart Failure 14 14
Pulmonary Valve Stenosis 13 13
Perforation of Vessels 12 12
Mitral Valve Insufficiency/ Regurgitation 12 12
Rupture 12 12
Pneumonia 12 12
Fever 10 10
Sepsis 10 10
Ventricular Fibrillation 10 10

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