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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 171 171

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 123 123
Crack 105 105
Fluid/Blood Leak 97 97
Material Deformation 95 95
Material Puncture/Hole 92 92
Mechanical Problem 73 73
Material Separation 55 55
Detachment of Device or Device Component 51 51
Break 44 44
Disconnection 40 40
Leak/Splash 37 37
Fracture 35 35
Obstruction of Flow 34 34
Material Twisted/Bent 22 22
Packaging Problem 21 21
Material Split, Cut or Torn 19 19
Insufficient Information 18 18
Nonstandard Device 17 17
Air/Gas in Device 17 17
Loss of or Failure to Bond 16 16
Gas/Air Leak 14 14
Migration 11 11
Difficult to Insert 11 11
Component Missing 11 11
Defective Component 10 10
Difficult to Remove 10 10
Device Markings/Labelling Problem 10 10
Physical Resistance/Sticking 9 9
Improper Flow or Infusion 8 8
Device Contamination with Chemical or Other Material 8 8
Material Rupture 8 8
Detachment Of Device Component 7 7
Defective Device 7 7
Material Integrity Problem 7 7
No Flow 6 6
Positioning Problem 6 6
Ejection Problem 6 6
Deformation Due to Compressive Stress 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
Split 5 5
Appropriate Term/Code Not Available 5 5
Misassembled During Installation 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
Infusion or Flow Problem 4 4
Difficult to Advance 4 4
Inflation Problem 4 4
Loose or Intermittent Connection 4 4
Unsealed Device Packaging 4 4
Material Too Rigid or Stiff 4 4
Increase in Pressure 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
Partial Blockage 3 3
Contamination 3 3
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
Material Too Soft/Flexible 3 3
Patient Device Interaction Problem 2 2
Explosion 2 2
Separation Problem 2 2
Premature Separation 2 2
No Apparent Adverse Event 2 2
Device Contaminated During Manufacture or Shipping 2 2
Collapse 2 2
Air Leak 2 2
Inaccurate Flow Rate 2 2
Entrapment of Device 2 2
Product Quality Problem 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
Microbial Contamination of Device 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 431 431
No Known Impact Or Consequence To Patient 136 136
Hemorrhage/Bleeding 93 94
No Consequences Or Impact To Patient 82 82
Blood Loss 42 42
Death 40 40
Insufficient Information 31 31
Cardiac Arrest 25 25
Hematoma 19 19
Cardiac Perforation 16 16
No Patient Involvement 15 15
Thrombosis/Thrombus 15 15
Air Embolism 15 15
Exsanguination 13 13
Perforation 11 11
No Code Available 11 11
Device Embedded In Tissue or Plaque 11 11
Vascular Dissection 10 10
Ischemia 10 10
Low Blood Pressure/ Hypotension 10 10
Perforation of Vessels 10 10
Cardiac Tamponade 10 10
Obstruction/Occlusion 8 8
No Information 7 7
Foreign Body In Patient 7 7
Pulmonary Embolism 7 7
Hypoxia 6 6
Respiratory Failure 6 6
Hypovolemia 6 6
Sepsis 6 6
Swelling/ Edema 6 6
Hemolysis 5 5
Unspecified Infection 5 5
Stroke/CVA 5 5
Embolism 4 4
Bacterial Infection 4 4
Bradycardia 4 4
Laceration(s) 4 4
Decreased Respiratory Rate 4 4
Aortic Dissection 4 4
Rupture 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Bronchopneumonia 4 4
Low Oxygen Saturation 3 3
Vascular System (Circulation), Impaired 3 3
Patient Problem/Medical Problem 3 3
Multiple Organ Failure 3 3
Tissue Damage 3 3
Venipuncture 3 3
Arrhythmia 3 3
Endocarditis 3 3
Cardiopulmonary Arrest 2 2
Airway Obstruction 2 2
Non specific EKG/ECG Changes 2 2
Pneumothorax 2 2
Extravasation 2 2
Pulmonary Edema 2 2
Pain 2 2
Thrombus 2 2
Brain Injury 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
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
Heart Failure/Congestive Heart Failure 1 1
Mitral Valve Insufficiency/ Regurgitation 1 1
Unspecified Heart Problem 1 1
Cough 1 1
Respiratory Arrest 1 1
Respiratory Insufficiency 1 1
Gastrointestinal Hemorrhage 1 1
Renal Impairment 1 1
Unspecified Tissue Injury 1 1
Thrombocytopenia 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
Excessive Tear Production 1 1
Ulcer 1 1
Hemolytic Anemia 1 1
Distress 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

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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