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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 4
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 3
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
SPYDER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SURGE CARDIOVASCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 101 101
2018 118 118
2019 178 178
2020 142 142
2021 162 162
2022 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 119 119
Fluid Leak 59 59
Crack 49 49
Break 45 45
Detachment of Device or Device Component 41 41
Disconnection 40 40
Material Separation 39 39
Leak/Splash 32 32
Mechanical Problem 31 31
Fracture 30 30
Material Puncture/Hole 26 26
Material Deformation 25 25
Insufficient Information 20 20
Packaging Problem 19 19
Material Split, Cut or Torn 16 16
Difficult to Remove 13 13
Nonstandard Device 13 13
Detachment Of Device Component 12 12
Material Twisted/Bent 12 12
Gas Leak 12 12
Migration 11 11
Difficult to Insert 10 10
Defective Component 9 9
Device Contamination with Chemical or Other Material 9 9
Device Operational Issue 8 8
Component Missing 8 8
Obstruction of Flow 8 8
Defective Device 7 7
Device Markings/Labelling Problem 7 7
Improper Flow or Infusion 7 7
Material Rupture 7 7
Air/Gas in Device 7 7
Device Slipped 6 6
Improper or Incorrect Procedure or Method 6 6
Material Integrity Problem 6 6
Positioning Problem 6 6
Device Handling Problem 6 6
Physical Resistance/Sticking 6 6
Device Displays Incorrect Message 6 6
Device Operates Differently Than Expected 6 6
Deformation Due to Compressive Stress 6 6
Split 5 5
Tear, Rip or Hole in Device Packaging 5 5
Manufacturing, Packaging or Shipping Problem 5 5
No Flow 5 5
Delivered as Unsterile Product 5 5
Loss of or Failure to Bond 5 5
Coagulation in Device or Device Ingredient 5 5
Material Discolored 5 5
Burst Container or Vessel 4 4
Partial Blockage 4 4
Material Too Rigid or Stiff 4 4
Unsealed Device Packaging 4 4
Insufficient Flow or Under Infusion 4 4
Appropriate Term/Code Not Available 4 4
Temperature Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Ejection Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Difficult to Advance 4 4
Device Dislodged or Dislocated 4 4
Malposition of Device 3 3
Failure to Deliver 3 3
Device Issue 3 3
Contamination /Decontamination Problem 3 3
Connection Problem 3 3
Noise, Audible 3 3
Unintended Movement 3 3
Unraveled Material 3 3
Off-Label Use 3 3
Particulates 3 3
Loose or Intermittent Connection 3 3
Backflow 3 3
Air Leak 3 3
Complete Blockage 3 3
Collapse 3 3
Positioning Failure 3 3
Material Fragmentation 3 3
Restricted Flow rate 3 3
Inaccurate Flow Rate 2 2
Hole In Material 2 2
Inflation Problem 2 2
Contamination 2 2
Decoupling 2 2
Deflation Problem 2 2
Difficult or Delayed Positioning 2 2
Shipping Damage or Problem 2 2
Use of Device Problem 2 2
Fitting Problem 2 2
Suction Problem 2 2
Material Perforation 2 2
No Apparent Adverse Event 2 2
Patient Device Interaction Problem 2 2
Material Too Soft/Flexible 2 2
Infusion or Flow Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Failure to Advance 2 2
Free or Unrestricted Flow 2 2
Physical Resistance 2 2
Separation Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 163 163
No Clinical Signs, Symptoms or Conditions 151 151
No Consequences Or Impact To Patient 97 97
Blood Loss 52 52
Death 50 50
Hemorrhage/Bleeding 46 47
Cardiac Arrest 21 21
Cardiac Perforation 20 20
Insufficient Information 20 20
No Patient Involvement 19 19
No Code Available 17 17
Hematoma 13 13
Perforation 13 13
Air Embolism 11 11
No Information 11 11
Cardiac Tamponade 10 10
Pulmonary Embolism 9 9
Foreign Body In Patient 9 9
Vascular Dissection 8 8
Exsanguination 8 8
Low Blood Pressure/ Hypotension 8 8
Perforation of Vessels 8 8
Ischemia 7 7
Device Embedded In Tissue or Plaque 7 7
Hypoxia 6 6
Tissue Damage 6 6
Aortic Dissection 6 6
Obstruction/Occlusion 6 6
Respiratory Failure 5 5
Hypovolemia 5 5
Sepsis 5 5
Rupture 5 5
Bronchopneumonia 4 4
Hemolysis 4 4
Bradycardia 4 4
Stroke/CVA 4 4
Embolism 4 4
Arrhythmia 3 3
Low Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Vascular System (Circulation), Impaired 3 3
Venipuncture 3 3
Patient Problem/Medical Problem 3 3
Pericardial Effusion 3 3
Embolism/Embolus 2 2
Thrombosis/Thrombus 2 2
Asystole 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Multiple Organ Failure 2 2
Not Applicable 2 2
Thrombus 2 2
Alteration In Body Temperature 2 2
Excessive Tear Production 2 2
Sudden Cardiac Death 2 2
Atrial Perforation 2 2
Airway Obstruction 2 2
Cardiopulmonary Arrest 2 2
Non specific EKG/ECG Changes 2 2
Extravasation 2 2
Laceration(s) 2 2
Mitral Regurgitation 1 1
Neurological Deficit/Dysfunction 1 1
Pain 1 1
Pneumothorax 1 1
Pulmonary Dysfunction 1 1
Pulmonary Edema 1 1
Scar Tissue 1 1
Hypothermia 1 1
Hyperbilirubinemia 1 1
High Blood Pressure/ Hypertension 1 1
Endocarditis 1 1
Chest Pain 1 1
Contusion 1 1
Dyspnea 1 1
Aortic Valve Stenosis 1 1
Atrial Flutter 1 1
Bacterial Infection 1 1
Myocardial Contusion 1 1
Ulcer 1 1
Sinus Perforation 1 1
Hemolytic Anemia 1 1
Injury 1 1
Sedation 1 1
Reaction 1 1
Numbness 1 1
Loss of consciousness 1 1
Brain Injury 1 1
Tingling 1 1
Heart Failure 1 1
Ventricular Tachycardia 1 1
Ulceration 1 1
Swelling 1 1
Thrombosis 1 1
Unspecified Infection 1 1
Inflammation 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

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 Medtronic Perfusion Systems II Jul-10-2017
14 OriGen Biomedical, Inc. I Jun-04-2019
15 OriGen Biomedical, Inc. I Nov-07-2018
16 OriGen Biomedical, Inc. II Oct-18-2018
17 OriGen Biomedical, Inc. II Oct-12-2018
18 OriGen Biomedical, Inc. I Oct-20-2017
19 SPS Sterilization, Inc II Sep-13-2018
20 Sorin Group USA, Inc. II Nov-08-2017
21 Sorin Group USA, Inc. II Aug-10-2017
22 Surge Medical Sales, LLC (DBA Surge Cardiovascular) II Oct-04-2018
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