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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device transducer, pressure, catheter tip
Product CodeDXO
Regulation Number 870.2870
Device Class 2


Premarket Reviews
ManufacturerDecision
ACIST MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFECIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC
  SUBSTANTIALLY EQUIVALENT 1
OPSENS INC.
  SUBSTANTIALLY EQUIVALENT 2
ZURICH MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 153 153
2020 158 158
2021 116 116
2022 144 144
2023 194 194
2024 164 164

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 169 169
Detachment of Device or Device Component 167 167
Communication or Transmission Problem 89 89
Material Separation 71 71
Incorrect Measurement 60 60
Contamination 55 55
Break 44 44
Failure to Advance 43 43
Difficult to Remove 40 40
Device Contamination with Chemical or Other Material 38 38
Adverse Event Without Identified Device or Use Problem 37 37
Fluid/Blood Leak 29 29
Fracture 29 29
Failure to Zero 24 24
Improper or Incorrect Procedure or Method 22 22
Leak/Splash 22 22
Difficult to Advance 21 21
Material Deformation 20 20
Contamination /Decontamination Problem 19 19
Deformation Due to Compressive Stress 17 17
Material Integrity Problem 15 15
Use of Device Problem 14 14
Disconnection 12 12
Material Split, Cut or Torn 11 11
Physical Resistance/Sticking 10 10
Output Problem 10 10
Entrapment of Device 10 10
Inaccurate Flow Rate 9 9
Stretched 8 8
Peeled/Delaminated 7 7
Device Contaminated During Manufacture or Shipping 7 7
Mechanical Problem 6 6
Loose or Intermittent Connection 6 6
Unsealed Device Packaging 6 6
Defective Device 6 6
Material Twisted/Bent 5 5
Calibration Problem 5 5
Air/Gas in Device 5 5
Pacing Problem 5 5
Failure to Clean Adequately 4 4
Positioning Problem 4 4
Mechanical Jam 4 4
Appropriate Term/Code Not Available 3 3
Flushing Problem 3 3
Inaccurate Information 3 3
Contamination of Device Ingredient or Reagent 3 3
Tear, Rip or Hole in Device Packaging 3 3
Defective Component 3 3
Insufficient Information 3 3
Material Frayed 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 494 494
No Consequences Or Impact To Patient 223 223
No Known Impact Or Consequence To Patient 129 129
Hemorrhage/Bleeding 25 25
Insufficient Information 21 21
Vascular Dissection 20 20
No Patient Involvement 18 18
Device Embedded In Tissue or Plaque 16 16
Foreign Body In Patient 14 14
Cerebrospinal Fluid Leakage 13 13
Air Embolism 9 9
No Code Available 9 9
Blood Loss 8 8
Low Blood Pressure/ Hypotension 7 7
Loss of consciousness 7 7
Pericardial Effusion 6 6
Burn(s) 6 6
Unspecified Infection 4 4
High Blood Pressure/ Hypertension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Death 2 2
Bradycardia 2 2
Thrombosis/Thrombus 2 2
Perforation 2 2
Vasoconstriction 2 2
Transient Ischemic Attack 2 2
Cardiac Arrest 2 2
Obstruction/Occlusion 2 2
Atrial Fibrillation 2 2
Cognitive Changes 1 1
Overdose 1 1
Electrolyte Imbalance 1 1
Cardiac Tamponade 1 1
Burn, Thermal 1 1
Hematoma 1 1
Hepatitis 1 1
Paralysis 1 1
Ventricular Fibrillation 1 1
Dizziness 1 1
Memory Loss/Impairment 1 1
Exposure to Body Fluids 1 1
Chest Pain 1 1
Thrombosis 1 1
Pain 1 1
Perforation of Vessels 1 1
Embolism/Embolus 1 1
Aneurysm 1 1
Tissue Damage 1 1
Superficial (First Degree) Burn 1 1
Cyanosis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Jun-25-2021
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