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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 280 280
2023 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 121 121
Crack 94 94
Fluid/Blood Leak 91 91
Material Deformation 82 82
Material Puncture/Hole 80 80
Mechanical Problem 55 55
Material Separation 50 50
Detachment of Device or Device Component 50 50
Break 43 43
Disconnection 40 40
Fracture 34 34
Obstruction of Flow 34 34
Leak/Splash 32 32
Material Twisted/Bent 22 22
Packaging Problem 21 21
Material Split, Cut or Torn 18 18
Insufficient Information 17 17
Nonstandard Device 17 17
Loss of or Failure to Bond 14 14
Gas/Air Leak 14 14
Air/Gas in Device 13 13
Migration 11 11
Difficult to Insert 11 11
Difficult to Remove 10 10
Defective Component 10 10
Component Missing 10 10
Device Markings/Labelling Problem 10 10
Physical Resistance/Sticking 9 9
Device Contamination with Chemical or Other Material 8 8
Improper Flow or Infusion 7 7
Defective Device 7 7
Material Integrity Problem 7 7
Material Rupture 7 7
Detachment Of Device Component 7 7
Coagulation in Device or Device Ingredient 6 6
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
No Flow 6 6
Positioning Problem 6 6
Ejection Problem 6 6
Deformation Due to Compressive Stress 6 6
Split 5 5
Appropriate Term/Code Not Available 5 5
Delivered as Unsterile Product 5 5
Material Discolored 5 5
Restricted Flow rate 5 5
Inflation Problem 4 4
Loose or Intermittent Connection 4 4
Unsealed Device Packaging 4 4
Material Too Rigid or Stiff 4 4
Insufficient Flow or Under Infusion 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Contamination /Decontamination Problem 4 4
Device Displays Incorrect Message 4 4
Difficult to Advance 4 4
Device Operates Differently Than Expected 3 3
Malposition of Device 3 3
Free or Unrestricted Flow 3 3
Connection Problem 3 3
Failure to Deliver 3 3
Inadequacy of Device Shape and/or Size 3 3
Tear, Rip or Hole in Device Packaging 3 3
Device Handling Problem 3 3
Noise, Audible 3 3
Misassembled During Installation 3 3
Unraveled Material 3 3
Increase in Pressure 3 3
Off-Label Use 3 3
Particulates 3 3
Material Fragmentation 3 3
Deflation Problem 3 3
Positioning Failure 3 3
Burst Container or Vessel 3 3
Complete Blockage 3 3
Backflow 3 3
Partial Blockage 3 3
Contamination 3 3
Material Too Soft/Flexible 3 3
Collapse 2 2
Air Leak 2 2
Inaccurate Flow Rate 2 2
Entrapment of Device 2 2
Suction Problem 2 2
Material Perforation 2 2
Separation Problem 2 2
Premature Separation 2 2
Patient Device Interaction Problem 2 2
Explosion 2 2
No Apparent Adverse Event 2 2
Infusion or Flow Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Human-Device Interface Problem 1 1
Aspiration Issue 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device Sensing Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 367 367
No Known Impact Or Consequence To Patient 136 136
Hemorrhage/Bleeding 85 86
No Consequences Or Impact To Patient 82 82
Blood Loss 42 42
Death 40 40
Insufficient Information 29 29
Cardiac Arrest 23 23
Hematoma 19 19
Cardiac Perforation 16 16
Air Embolism 15 15
Thrombosis/Thrombus 15 15
No Patient Involvement 15 15
Exsanguination 13 13
Perforation 11 11
Device Embedded In Tissue or Plaque 11 11
No Code Available 11 11
Vascular Dissection 10 10
Ischemia 10 10
Low Blood Pressure/ Hypotension 10 10
Cardiac Tamponade 10 10
Perforation of Vessels 10 10
Obstruction/Occlusion 8 8
Pulmonary Embolism 7 7
No Information 7 7
Foreign Body In Patient 7 7
Swelling/ Edema 6 6
Hypoxia 6 6
Respiratory Failure 6 6
Hypovolemia 6 6
Sepsis 6 6
Unspecified Infection 5 5
Hemolysis 5 5
Laceration(s) 4 4
Stroke/CVA 4 4
Embolism 4 4
Bacterial Infection 4 4
Bradycardia 4 4
Rupture 4 4
Bronchopneumonia 4 4
Aortic Dissection 4 4
Vascular System (Circulation), Impaired 3 3
Low Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Tissue Damage 3 3
Venipuncture 3 3
Arrhythmia 3 3
Endocarditis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Patient Problem/Medical Problem 3 3
Multiple Organ Failure 3 3
Pericardial Effusion 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Alteration In Body Temperature 2 2
Embolism/Embolus 2 2
Asystole 2 2
Cardiopulmonary Arrest 2 2
Airway Obstruction 2 2
Pneumothorax 2 2
Extravasation 2 2
Pulmonary Edema 2 2
Non specific EKG/ECG Changes 2 2
Thrombus 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Brain Injury 2 2
Excessive Tear Production 1 1
Ulcer 1 1
Hemolytic Anemia 1 1
Sedation 1 1
Reaction 1 1
Numbness 1 1
Loss of consciousness 1 1
Scar Tissue 1 1
Septic Shock 1 1
Swelling 1 1
Tachycardia 1 1
Thrombosis 1 1
Ventricular Tachycardia 1 1
Ulceration 1 1
Tingling 1 1
Heart Failure 1 1
Hyperbilirubinemia 1 1
High Blood Pressure/ Hypertension 1 1
Pulmonary Dysfunction 1 1
Pneumonia 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Aortic Valve Stenosis 1 1
Atrial Flutter 1 1
Myocardial Contusion 1 1
Chest Pain 1 1
Contusion 1 1
Dyspnea 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 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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