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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 2

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 444 444

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1433 1433
Material Twisted/Bent 580 580
Patient Device Interaction Problem 290 290
Material Deformation 286 286
Entrapment of Device 170 170
Material Integrity Problem 156 156
Fracture 92 92
Signal Artifact/Noise 91 91
Difficult to Remove 88 88
Detachment of Device or Device Component 63 63
Material Separation 61 61
Compatibility Problem 56 56
Communication or Transmission Problem 49 49
Mechanical Problem 48 48
Material Frayed 44 44
Contamination /Decontamination Problem 40 40
Break 38 38
Fluid/Blood Leak 38 38
Mechanical Jam 33 33
Activation, Positioning or Separation Problem 33 33
Display or Visual Feedback Problem 29 29
Material Protrusion/Extrusion 27 27
Defective Device 26 26
Device Contamination with Chemical or Other Material 24 24
Positioning Problem 24 24
Device-Device Incompatibility 24 24
Difficult to Insert 23 23
Material Perforation 22 22
Insufficient Information 21 21
Leak/Splash 20 20
Improper Flow or Infusion 19 19
Coagulation in Device or Device Ingredient 18 18
Tear, Rip or Hole in Device Packaging 17 17
Delivered as Unsterile Product 16 16
Obstruction of Flow 16 16
Device Contamination with Body Fluid 14 14
Manufacturing, Packaging or Shipping Problem 14 14
Material Split, Cut or Torn 14 14
Appropriate Term/Code Not Available 13 13
Material Puncture/Hole 12 12
Contamination 12 12
Use of Device Problem 12 12
Component Misassembled 11 11
Device Displays Incorrect Message 10 10
Poor Quality Image 10 10
Packaging Problem 10 10
Failure to Sense 10 10
Output Problem 7 7
Electrical Shorting 7 7
Data Problem 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1308 1308
Cardiac Tamponade 530 530
Cardiac Perforation 438 438
Pericardial Effusion 394 394
No Consequences Or Impact To Patient 359 359
Low Blood Pressure/ Hypotension 239 239
No Known Impact Or Consequence To Patient 173 173
Stroke/CVA 133 133
Hematoma 66 66
Fistula 60 60
Hemorrhage/Bleeding 59 59
Heart Block 58 58
Death 57 57
Insufficient Information 52 52
Pseudoaneurysm 49 49
Cardiac Arrest 46 46
Chest Pain 42 42
Transient Ischemic Attack 36 36
Arrhythmia 36 36
Vascular Dissection 33 33
No Code Available 32 32
Thrombosis/Thrombus 32 32
Tachycardia 30 30
Non specific EKG/ECG Changes 23 23
Inflammation 23 23
Hemoptysis 23 23
Air Embolism 22 22
Foreign Body In Patient 22 22
Perforation 22 22
Unspecified Tissue Injury 21 21
Paralysis 20 20
Dyspnea 17 17
Ischemia Stroke 16 16
Embolism/Embolus 16 16
Atrial Fibrillation 15 15
Bradycardia 15 15
No Patient Involvement 15 15
Pericarditis 14 14
Nerve Damage 14 14
Myocardial Infarction 13 13
Tissue Damage 13 13
Pulmonary Valve Stenosis 12 12
Atrial Flutter 12 12
Perforation of Vessels 12 12
Mitral Valve Insufficiency/ Regurgitation 11 11
Rupture 11 11
Fever 11 11
Physical Entrapment 10 10
Great Vessel Perforation 10 10
Heart Failure/Congestive Heart Failure 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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