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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 2
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 117 117
Fluid/Blood Leak 81 81
Crack 68 68
Material Puncture/Hole 66 66
Material Separation 49 49
Mechanical Problem 48 48
Detachment of Device or Device Component 47 47
Material Deformation 42 42
Break 42 42
Disconnection 39 39
Fracture 31 31
Leak/Splash 29 29
Obstruction of Flow 28 28
Packaging Problem 19 19
Nonstandard Device 17 17
Material Twisted/Bent 16 16
Insufficient Information 16 16
Material Split, Cut or Torn 16 16
Gas/Air Leak 13 13
Loss of or Failure to Bond 12 12
Difficult to Insert 11 11
Migration 11 11
Air/Gas in Device 11 11
Difficult to Remove 10 10
Defective Component 10 10
Device Markings/Labelling Problem 9 9
Device Contamination with Chemical or Other Material 8 8
Physical Resistance/Sticking 8 8
Component Missing 8 8
Material Rupture 7 7
Detachment Of Device Component 7 7
Improper Flow or Infusion 7 7
Defective Device 7 7
Deformation Due to Compressive Stress 6 6
Material Integrity Problem 6 6
Positioning Problem 6 6
Coagulation in Device or Device Ingredient 6 6
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
Delivered as Unsterile Product 5 5
Material Discolored 5 5
Restricted Flow rate 5 5
No Flow 5 5
Appropriate Term/Code Not Available 5 5
Split 5 5
Contamination /Decontamination Problem 4 4
Device Displays Incorrect Message 4 4
Difficult to Advance 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Unintended Movement 4 4
Ejection Problem 4 4
Manufacturing, Packaging or Shipping Problem 4 4
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
Unraveled Material 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
Contamination 3 3
Noise, Audible 3 3
Device Handling Problem 3 3
Device Operates Differently Than Expected 3 3
Free or Unrestricted Flow 3 3
Malposition of Device 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
Infusion or Flow Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Patient Device Interaction Problem 2 2
No Apparent Adverse Event 2 2
Explosion 2 2
Material Too Soft/Flexible 2 2
Separation Problem 2 2
Premature Separation 2 2
Collapse 2 2
Partial Blockage 2 2
Air Leak 2 2
Inaccurate Flow Rate 2 2
Entrapment of Device 2 2
Increase in Pressure 2 2
Suction Problem 2 2
Material Perforation 2 2
Device Damaged Prior to Use 1 1
Fitting Problem 1 1
Unknown (for use when the device problem is not known) 1 1
Device Contamination with Body Fluid 1 1
Microbial Contamination of Device 1 1
Use of Device Problem 1 1
Vibration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 292
No Known Impact Or Consequence To Patient 136 136
No Consequences Or Impact To Patient 82 82
Hemorrhage/Bleeding 72 73
Blood Loss 42 42
Death 40 40
Insufficient Information 27 27
Cardiac Arrest 23 23
Hematoma 19 19
Cardiac Perforation 16 16
Air Embolism 15 15
No Patient Involvement 15 15
Thrombosis/Thrombus 14 14
Device Embedded In Tissue or Plaque 11 11
No Code Available 11 11
Perforation 11 11
Ischemia 10 10
Exsanguination 10 10
Low Blood Pressure/ Hypotension 10 10
Vascular Dissection 10 10
Cardiac Tamponade 9 9
Perforation of Vessels 9 9
Obstruction/Occlusion 7 7
Pulmonary Embolism 7 7
No Information 7 7
Foreign Body In Patient 6 6
Swelling/ Edema 6 6
Hypoxia 6 6
Respiratory Failure 6 6
Hypovolemia 6 6
Sepsis 6 6
Rupture 4 4
Bronchopneumonia 4 4
Aortic Dissection 4 4
Unspecified Infection 4 4
Hemolysis 4 4
Laceration(s) 4 4
Embolism 4 4
Bradycardia 4 4
Stroke/CVA 4 4
Arrhythmia 3 3
Vascular System (Circulation), Impaired 3 3
Low Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Tissue Damage 3 3
Venipuncture 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
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
Airway Obstruction 2 2
Bacterial Infection 2 2
Cardiopulmonary Arrest 2 2
Pneumothorax 2 2
Extravasation 2 2
Hyperbilirubinemia 1 1
High Blood Pressure/ Hypertension 1 1
Pulmonary Dysfunction 1 1
Pneumonia 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Chest Pain 1 1
Contusion 1 1
Endocarditis 1 1
Dyspnea 1 1
Myocardial Contusion 1 1
Aortic Valve Stenosis 1 1
Atrial Flutter 1 1
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
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Respiratory Arrest 1 1
Gastrointestinal Hemorrhage 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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