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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, septostomy
Regulation Description Septostomy catheter.
Product CodeDXF
Regulation Number 870.5175
Device Class 2


Premarket Reviews
ManufacturerDecision
ATRAVERSE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
  1.  K240900  HOTWIRE™ RF Guidewire
BAYLIS MEDICAL COMPANY
  SUBSTANTIALLY EQUIVALENT 1
CIRCA SCIENTIFIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
CROSS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 55 55
2021 39 39
2022 70 70
2023 288 288
2024 368 368
2025 86 86

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 457 457
Failure to Advance 102 102
Difficult to Advance 90 90
Display or Visual Feedback Problem 64 64
Material Integrity Problem 58 58
Positioning Problem 57 57
Material Deformation 44 44
Use of Device Problem 29 29
Detachment of Device or Device Component 26 26
Physical Resistance/Sticking 25 25
Device-Device Incompatibility 17 17
Burst Container or Vessel 14 14
Insufficient Information 14 14
Difficult to Remove 12 12
Material Frayed 11 11
Defective Device 11 11
Device Dislodged or Dislocated 9 9
Thermal Decomposition of Device 8 8
Contamination 7 7
Deformation Due to Compressive Stress 5 5
Device Displays Incorrect Message 5 5
Packaging Problem 5 5
Tear, Rip or Hole in Device Packaging 4 4
Material Rupture 4 4
Difficult to Insert 4 4
Unsealed Device Packaging 4 4
Break 4 4
Obstruction of Flow 3 3
Device Contaminated During Manufacture or Shipping 3 3
Leak/Splash 3 3
Unintended Movement 2 2
Positioning Failure 2 2
Device Markings/Labelling Problem 2 2
Difficult or Delayed Positioning 2 2
High impedance 2 2
Device Contamination with Chemical or Other Material 2 2
Fracture 2 2
Failure to Deliver Energy 2 2
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Component Missing 1 1
Improper Flow or Infusion 1 1
Difficult to Open or Remove Packaging Material 1 1
Mechanics Altered 1 1
Communication or Transmission Problem 1 1
Off-Label Use 1 1
Electromagnetic Compatibility Problem 1 1
Mechanical Problem 1 1
Entrapment of Device 1 1
Failure to Fire 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 412 412
No Clinical Signs, Symptoms or Conditions 241 241
Low Blood Pressure/ Hypotension 192 192
Cardiac Tamponade 177 177
Cardiac Perforation 134 134
Thrombosis/Thrombus 60 60
Perforation of Vessels 42 42
Perforation 36 36
Hematoma 31 31
Cardiac Arrest 30 30
Hemorrhage/Bleeding 25 25
Arrhythmia 17 17
Bradycardia 14 14
Stroke/CVA 13 13
Tachycardia 13 13
Air Embolism 11 11
No Consequences Or Impact To Patient 10 10
Asystole 10 10
Chest Pain 9 9
Dyspnea 6 6
Hemothorax 6 6
Vascular Dissection 6 6
Non specific EKG/ECG Changes 6 6
Atrial Fibrillation 5 5
Ventricular Fibrillation 5 5
Foreign Body In Patient 5 5
Fistula 5 5
Heart Block 5 5
Insufficient Information 5 5
High Blood Pressure/ Hypertension 5 5
Embolism/Embolus 4 4
Respiratory Arrest 4 4
Pleural Effusion 4 4
Death 4 4
Hypoxia 4 4
Pseudoaneurysm 4 4
Diminished Pulse Pressure 3 3
Transient Ischemic Attack 3 3
Burn(s) 3 3
Intracranial Hemorrhage 3 3
Ischemia 2 2
Hemoptysis 2 2
Pericarditis 2 2
Needle Stick/Puncture 2 2
Diaphoresis 2 2
Pain 2 2
Thromboembolism 2 2
Shock 2 2
Electric Shock 2 2
Loss of consciousness 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Vascular I Oct-16-2020
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