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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, cannula and tubing, vascular, cardiopulmonary bypass
Product CodeDWF
Regulation Number 870.4210
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIACASSIST INC
  SUBSTANTIALLY EQUIVALENT 1
CARDIOGARD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
KAPP SURGICAL INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 118 118
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 446 446

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 153 153
Adverse Event Without Identified Device or Use Problem 147 147
Material Puncture/Hole 127 127
Fluid/Blood Leak 125 125
Crack 121 121
Mechanical Problem 114 114
Material Separation 92 92
Break 56 56
Detachment of Device or Device Component 54 54
Obstruction of Flow 49 49
Leak/Splash 41 41
Disconnection 40 40
Fracture 38 38
Insufficient Information 29 29
Material Twisted/Bent 24 24
Packaging Problem 22 22
Air/Gas in Device 20 20
Material Split, Cut or Torn 19 19
Loss of or Failure to Bond 18 18
Nonstandard Device 17 17
Gas/Air Leak 14 14
Component Missing 13 13
Difficult to Insert 13 13
Migration 12 12
Device Markings/Labelling Problem 11 11
Defective Component 10 10
Difficult to Remove 10 10
Defective Device 9 9
Physical Resistance/Sticking 9 9
Improper Flow or Infusion 9 9
Device Contamination with Chemical or Other Material 8 8
Material Rupture 8 8
Misassembled During Installation 8 8
Detachment Of Device Component 7 7
Deformation Due to Compressive Stress 7 7
Material Integrity Problem 7 7
No Flow 6 6
Infusion or Flow Problem 6 6
Positioning Problem 6 6
Ejection Problem 6 6
Appropriate Term/Code Not Available 6 6
Coagulation in Device or Device Ingredient 6 6
Loose or Intermittent Connection 6 6
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
Increase in Pressure 6 6
Delivered as Unsterile Product 5 5
Unsealed Device Packaging 5 5
Material Discolored 5 5
Inflation Problem 5 5
Restricted Flow rate 5 5
Contamination 5 5
Device Handling Problem 5 5
Malposition of Device 5 5
Split 5 5
Tear, Rip or Hole in Device Packaging 4 4
Contamination /Decontamination Problem 4 4
Connection Problem 4 4
Difficult to Advance 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Device Displays Incorrect Message 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Partial Blockage 4 4
Positioning Failure 4 4
Material Too Rigid or Stiff 4 4
Insufficient Flow or Under Infusion 4 4
Unraveled Material 3 3
Use of Device Problem 3 3
Off-Label Use 3 3
Particulates 3 3
Deflation Problem 3 3
Material Fragmentation 3 3
Backflow 3 3
Burst Container or Vessel 3 3
Complete Blockage 3 3
Noise, Audible 3 3
Free or Unrestricted Flow 3 3
Device Operates Differently Than Expected 3 3
Inadequacy of Device Shape and/or Size 3 3
Failure to Deliver 3 3
Material Too Soft/Flexible 3 3
Failure to Advance 2 2
Difficult to Open or Close 2 2
Device Dislodged or Dislocated 2 2
Patient Device Interaction Problem 2 2
Protective Measures Problem 2 2
No Apparent Adverse Event 2 2
Explosion 2 2
Separation Problem 2 2
Premature Separation 2 2
Device Contaminated During Manufacture or Shipping 2 2
Air Leak 2 2
Decoupling 2 2
Collapse 2 2
Inaccurate Flow Rate 2 2
Entrapment of Device 2 2
Device Difficult to Setup or Prepare 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 646 646
No Known Impact Or Consequence To Patient 136 136
Hemorrhage/Bleeding 113 114
No Consequences Or Impact To Patient 82 82
Blood Loss 42 42
Death 40 40
Insufficient Information 33 33
Cardiac Arrest 27 27
Hematoma 22 22
Perforation of Vessels 17 17
Cardiac Perforation 17 17
Thrombosis/Thrombus 17 17
Exsanguination 16 16
Air Embolism 16 16
No Patient Involvement 15 15
Ischemia 14 14
Perforation 14 14
Low Blood Pressure/ Hypotension 13 13
Vascular Dissection 12 12
Device Embedded In Tissue or Plaque 12 12
No Code Available 11 11
Cardiac Tamponade 11 11
Obstruction/Occlusion 8 8
Swelling/ Edema 8 8
Foreign Body In Patient 7 7
No Information 7 7
Hypovolemia 7 7
Sepsis 7 7
Unspecified Infection 7 7
Pulmonary Embolism 7 7
Bradycardia 6 6
Hypoxia 6 6
Hemolysis 6 6
Respiratory Failure 6 6
Stroke/CVA 5 5
Bacterial Infection 5 5
Laceration(s) 4 4
Embolism 4 4
Rupture 4 4
Decreased Respiratory Rate 4 4
Aortic Dissection 4 4
Bronchopneumonia 4 4
Multiple Organ Failure 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Pulmonary Hypertension 3 3
Pericardial Effusion 3 3
Low Oxygen Saturation 3 3
Vascular System (Circulation), Impaired 3 3
Patient Problem/Medical Problem 3 3
Brain Injury 3 3
Tissue Damage 3 3
Venipuncture 3 3
Endocarditis 3 3
Arrhythmia 3 3
Airway Obstruction 2 2
Cardiopulmonary Arrest 2 2
Extravasation 2 2
Non specific EKG/ECG Changes 2 2
Pulmonary Edema 2 2
Pain 2 2
Thrombus 2 2
Pneumothorax 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Asystole 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Alteration In Body Temperature 2 2
Embolism/Embolus 2 2
Thrombocytopenia 1 1
Heart Failure/Congestive Heart Failure 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Convulsion/Seizure 1 1
Diminished Pulse Pressure 1 1
Complete Heart Block 1 1
Nerve Proximity Nos (Not Otherwise Specified) 1 1
Thromboembolism 1 1
Intermenstrual Bleeding 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Gastrointestinal Hemorrhage 1 1
Renal Impairment 1 1
Unspecified Tissue Injury 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Pulmonary Dysfunction 1 1
Pleural Effusion 1 1
Pneumonia 1 1
Septic Shock 1 1
Swelling 1 1
Tachycardia 1 1
Thrombosis 1 1
Renal Failure 1 1
Scar Tissue 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Ulceration 1 1
Excessive Tear Production 1 1
Blurred Vision 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiac Assist, Inc III Nov-29-2021
2 Cardiac Assist, Inc II Feb-07-2020
3 Edwards Lifesciences, LLC II Jan-10-2020
4 Edwards Lifesciences, LLC II Nov-18-2019
5 LivaNova USA II Jan-23-2019
6 LivaNova USA Inc. II Jun-26-2020
7 Maquet Cardiopulmonary Ag II Jun-11-2018
8 Maquet Cardiovascular, LLC II May-31-2019
9 Medtronic Perfusion Systems II Jan-12-2022
10 Medtronic Perfusion Systems II Oct-01-2021
11 Medtronic Perfusion Systems II Jun-16-2021
12 Medtronic Perfusion Systems II Jan-30-2018
13 OriGen Biomedical, Inc. I Jun-04-2019
14 OriGen Biomedical, Inc. I Nov-07-2018
15 OriGen Biomedical, Inc. II Oct-18-2018
16 OriGen Biomedical, Inc. II Oct-12-2018
17 SPS Sterilization, Inc II Sep-13-2018
18 Surge Medical Sales, LLC (DBA Surge Cardiovascular) II Oct-04-2018
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