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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 10
BIOTRONICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHRXLTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 6
MEDFACT ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC ABLATION FRONTIERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMIA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 2 6 1 1 3 7 3 1 0

MDR Year MDR Reports MDR Events
2014 349 349
2015 325 325
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 444 444

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2311 2311
Material Twisted/Bent 642 642
Material Deformation 333 333
Patient Device Interaction Problem 290 290
Entrapment of Device 234 234
Insufficient Information 204 204
Material Integrity Problem 176 176
Difficult to Remove 148 148
Signal Artifact/Noise 120 120
Appropriate Term/Code Not Available 117 117
Break 116 116
Fracture 112 112
Device Operates Differently Than Expected 110 110
Material Separation 86 86
Detachment of Device or Device Component 76 76
Kinked 75 75
Device Contamination with Chemical or Other Material 75 75
Device Displays Incorrect Message 62 62
Communication or Transmission Problem 61 61
Mechanical Problem 58 58
Compatibility Problem 56 56
Material Frayed 53 53
Fluid/Blood Leak 51 51
Mechanical Jam 48 48
Positioning Problem 46 46
Contamination /Decontamination Problem 43 43
Activation, Positioning or Separation Problem 42 42
Detachment Of Device Component 42 42
Noise, Audible 41 41
Sticking 41 41
Device Sensing Problem 35 35
Display or Visual Feedback Problem 33 33
Material Protrusion/Extrusion 32 32
Defective Device 31 31
Difficult to Insert 29 29
Improper Flow or Infusion 29 29
Failure to Sense 29 29
Leak/Splash 24 24
Device-Device Incompatibility 24 24
Material Perforation 23 23
Delivered as Unsterile Product 20 20
Material Split, Cut or Torn 20 20
Coagulation in Device or Device Ingredient 19 19
Contamination 19 19
Tear, Rip or Hole in Device Packaging 19 19
Bent 18 18
Device Dislodged or Dislocated 16 16
Use of Device Problem 16 16
Obstruction of Flow 16 16
Manufacturing, Packaging or Shipping Problem 16 16

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1308 1308
Cardiac Tamponade 828 828
No Consequences Or Impact To Patient 823 823
Cardiac Perforation 777 777
Pericardial Effusion 670 670
No Known Impact Or Consequence To Patient 537 537
Low Blood Pressure/ Hypotension 436 436
Stroke/CVA 171 171
Death 145 145
Fistula 112 114
Hematoma 109 111
No Code Available 98 98
Hemorrhage/Bleeding 81 81
Cardiac Arrest 78 78
Pseudoaneurysm 72 72
Chest Pain 65 65
No Patient Involvement 62 62
Vascular Dissection 61 61
Heart Block 58 58
Arrhythmia 57 57
Transient Ischemic Attack 55 55
Insufficient Information 52 52
Tachycardia 43 43
Perforation 42 42
Air Embolism 40 40
Tissue Damage 36 36
Hemoptysis 34 34
Thrombosis/Thrombus 32 32
Complete Heart Block 30 30
Foreign Body In Patient 29 29
Bradycardia 28 28
Paralysis 27 27
ST Segment Elevation 26 26
Atrial Fibrillation 25 25
Blood Loss 25 25
Dyspnea 25 25
Inflammation 24 24
Partial thickness (Second Degree) Burn 24 24
Thrombosis 23 23
Non specific EKG/ECG Changes 23 23
Rupture 22 22
Nerve Damage 21 21
Unspecified Tissue Injury 21 21
Fever 20 20
No Information 20 20
Thrombus 19 19
Perforation of Vessels 18 18
Embolism 18 18
Vascular System (Circulation), Impaired 17 17
Myocardial Infarction 16 16

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Sep-19-2018
2 Biosense Webster, Inc. II Apr-27-2015
3 Biosense Webster, Inc. II Mar-03-2015
4 Biosense Webster, Inc. II Jun-28-2013
5 Biosense Webster, Inc. II May-22-2012
6 Biosense Webster, Inc. III Aug-18-2011
7 Biosense Webster, Inc. II Jun-27-2011
8 Boston Scientific Corp II Dec-10-2014
9 Irvine Biomedical Inc, a St. Jude Medical Co. II Sep-24-2020
10 Medtronic Inc. II Nov-02-2015
11 St Jude Medical II Nov-06-2014
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