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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 3
CARDIAC ASSIST, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIACASSIST INC
  SUBSTANTIALLY EQUIVALENT 1
CARDIACASSIST INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIOGARD MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC.
  SUBSTANTIALLY EQUIVALENT 12
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KAPP SURGICAL INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONIX LLC
  SUBSTANTIALLY EQUIVALENT 1
LEVITRONIX LLC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE, INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 11
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 13
NOVALUNG GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORIGEN BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
QURA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SORIN GROUP ITALIA S.R.L
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
SPYDER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SURGE CARDIOVASCULAR
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
THORATEC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1
VORTEX MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 325 325
2015 218 218
2016 144 144
2017 101 101
2018 118 118
2019 178 178
2020 142 142
2021 162 162
2022 276 276
2023 471 471
2024 65 65

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 263 263
Material Deformation 183 183
Fluid/Blood Leak 169 169
Crack 147 147
Mechanical Problem 143 143
Material Puncture/Hole 142 142
Material Separation 117 117
Leak/Splash 112 112
Break 109 109
Detachment of Device or Device Component 63 63
Disconnection 55 55
Fracture 54 54
Device Operates Differently Than Expected 53 53
Obstruction of Flow 52 52
Nonstandard Device 49 49
Insufficient Information 48 48
Detachment Of Device Component 40 40
Component Missing 36 36
Loss of or Failure to Bond 26 26
Packaging Problem 26 26
Difficult to Remove 25 25
Inflation Problem 24 24
Material Twisted/Bent 24 24
Material Split, Cut or Torn 21 21
Difficult to Insert 21 21
Material Rupture 20 20
Air/Gas in Device 20 20
Material Integrity Problem 18 18
Device Contaminated During Manufacture or Shipping 18 18
Device Dislodged or Dislocated 17 17
Air Leak 17 17
Device Misassembled During Manufacturing /Shipping 16 16
Device Contamination with Chemical or Other Material 16 16
Tear, Rip or Hole in Device Packaging 15 15
Kinked 15 15
Misassembled 14 14
Gas/Air Leak 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Migration 13 13
Improper Flow or Infusion 12 12
Migration or Expulsion of Device 12 12
Defective Component 12 12
Other (for use when an appropriate device code cannot be identified) 12 12
Use of Device Problem 11 11
Device Markings/Labelling Problem 11 11
Cut In Material 11 11
Defective Device 11 11
Increase in Pressure 11 11
Misassembled During Installation 11 11
Infusion or Flow Problem 10 10
Positioning Problem 10 10
Occlusion Within Device 10 10
Device Slipped 10 10
Connection Problem 9 9
Delivered as Unsterile Product 9 9
Loose or Intermittent Connection 9 9
Partial Blockage 9 9
No Flow 9 9
Appropriate Term/Code Not Available 9 9
Device Handling Problem 9 9
Physical Resistance/Sticking 9 9
Material Fragmentation 8 8
Hole In Material 8 8
Particulates 8 8
Device Operational Issue 8 8
Device Packaging Compromised 8 8
Deformation Due to Compressive Stress 8 8
Device Displays Incorrect Message 8 8
Malposition of Device 8 8
Split 8 8
Improper or Incorrect Procedure or Method 8 8
Insufficient Flow or Under Infusion 8 8
Inadequacy of Device Shape and/or Size 7 7
Unsealed Device Packaging 7 7
Deflation Problem 7 7
Unintended Movement 7 7
Material Protrusion/Extrusion 7 7
Temperature Problem 6 6
Ejection Problem 6 6
Contamination 6 6
Entrapment of Device 6 6
Burst Container or Vessel 6 6
Bent 6 6
Coagulation in Device or Device Ingredient 6 6
Difficult To Position 6 6
Restricted Flow rate 6 6
Failure to Advance 6 6
Contamination /Decontamination Problem 6 6
Difficult to Advance 5 5
Fitting Problem 5 5
Positioning Failure 5 5
Material Discolored 5 5
Suction Problem 4 4
Material Too Rigid or Stiff 4 4
Device Or Device Fragments Location Unknown 4 4
Therapeutic or Diagnostic Output Failure 4 4
Noise, Audible 4 4
Human-Device Interface Problem 4 4
Free or Unrestricted Flow 3 3
Incorrect Device Or Component Shipped 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 727 727
No Known Impact Or Consequence To Patient 355 355
No Consequences Or Impact To Patient 225 225
Hemorrhage/Bleeding 129 130
No Patient Involvement 115 115
Death 110 110
Blood Loss 64 64
Perforation 43 43
Cardiac Arrest 38 38
Cardiac Perforation 37 37
No Code Available 37 37
Insufficient Information 34 34
No Information 30 30
Hematoma 29 29
Exsanguination 23 23
Device Embedded In Tissue or Plaque 23 23
Perforation of Vessels 22 22
Pulmonary Embolism 21 21
Vascular Dissection 21 21
Foreign Body In Patient 21 21
Low Blood Pressure/ Hypotension 20 20
Air Embolism 18 18
Thrombosis/Thrombus 17 17
Aortic Dissection 15 15
Cardiac Tamponade 14 14
Ischemia 14 14
Not Applicable 12 12
Stroke/CVA 11 11
Hypoxia 8 8
Unspecified Infection 8 8
Low Oxygen Saturation 8 8
Obstruction/Occlusion 8 8
Swelling/ Edema 8 8
Respiratory Failure 7 7
Hypovolemia 7 7
Rupture 7 7
Sinus Perforation 7 7
Sepsis 7 7
Bradycardia 7 7
Embolism 7 7
Hemolysis 6 6
Tissue Damage 6 6
Great Vessel Perforation 5 5
Bacterial Infection 5 5
Arrhythmia 5 5
Foreign body, removal of 5 5
Thrombus 5 5
Atrial Perforation 5 5
Multiple Organ Failure 5 5
Pericardial Effusion 4 4
Patient Problem/Medical Problem 4 4
No Patient involvement 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Surgical procedure, additional 4 4
Vascular System (Circulation), Impaired 4 4
Bronchopneumonia 4 4
Decreased Respiratory Rate 4 4
Brain Injury 4 4
Thrombosis 4 4
Laceration(s) 4 4
Neurological Deficit/Dysfunction 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pain 3 3
Venipuncture 3 3
Endocarditis 3 3
Extravasation 3 3
Heart Failure 3 3
Complaint, Ill-Defined 3 3
Injury 3 3
Sudden Cardiac Death 3 3
Pulmonary Hypertension 3 3
Unspecified Tissue Injury 2 2
Asystole 2 2
Hemorrhagic Stroke 2 2
Ischemia Stroke 2 2
Thrombocytopenia 2 2
Embolism/Embolus 2 2
Alteration In Body Temperature 2 2
Low Cardiac Output 2 2
Excessive Tear Production 2 2
Erythema 2 2
Cardiomyopathy 2 2
Cardiopulmonary Arrest 2 2
Hemorrhage, Cerebral 2 2
Airway Obstruction 2 2
Non specific EKG/ECG Changes 2 2
Swelling 2 2
Pneumothorax 2 2
Pleural Effusion 2 2
Pulmonary Edema 2 2
Renal Failure 2 2
Left Ventricular Failure 2 2
Inflammation 2 2
Failure of Implant 1 1
Mitral Regurgitation 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Pneumonia 1 1
Pulmonary Dysfunction 1 1
Septic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vas II Aug-26-2009
2 Cardiac Assist, Inc III Nov-29-2021
3 Cardiac Assist, Inc II Feb-07-2020
4 Cardiac Assist, Inc II Jan-10-2011
5 Edwards Lifesciences Llc II May-13-2011
6 Edwards Lifesciences Llc II Jan-28-2011
7 Edwards Lifesciences, LLC II Jan-10-2020
8 Edwards Lifesciences, LLC II Nov-18-2019
9 Edwards Lifesciences, LLC II Dec-09-2015
10 Edwards Lifesciences, LLC II Apr-02-2015
11 Edwards Lifesciences, LLC II Nov-14-2014
12 Edwards Lifesciences, LLC II Apr-16-2014
13 Edwards Lifesciences, LLC II Nov-01-2013
14 Edwards Lifesciences, LLC I Oct-31-2013
15 Edwards Lifesciences, LLC II Aug-14-2013
16 Edwards Lifesciences, LLC II Aug-14-2013
17 Edwards Lifesciences, LLC II Jul-17-2013
18 Edwards Lifesciences, LLC II May-14-2013
19 Edwards Lifesciences, LLC II Apr-14-2013
20 Edwards Lifesciences, LLC II Jul-09-2012
21 Edwards Lifesciences, LLC II Jul-11-2011
22 LivaNova USA II Jan-23-2019
23 LivaNova USA Inc. II Jun-26-2020
24 Maquet Cardiopulmonary Ag II Jun-11-2018
25 Maquet Cardiovascular II Aug-31-2009
26 Maquet Cardiovascular Us Sales, Llc II Feb-20-2013
27 Maquet Cardiovascular, LLC II May-31-2019
28 Medtronic Cardiovascular Revascularization & Surgical Therap II Jan-26-2009
29 Medtronic Inc. Cardiac Rhythm Disease Management II Feb-20-2014
30 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-27-2013
31 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-05-2013
32 Medtronic Inc. Cardiac Rhythm Disease Management II Dec-28-2012
33 Medtronic Inc. Cardiac Rhythm Disease Management II Jan-18-2012
34 Medtronic Perfusion Systems II Mar-19-2024
35 Medtronic Perfusion Systems II Jan-12-2022
36 Medtronic Perfusion Systems II Oct-01-2021
37 Medtronic Perfusion Systems II Jun-16-2021
38 Medtronic Perfusion Systems II Jan-30-2018
39 Medtronic Perfusion Systems II Jul-10-2017
40 Medtronic Perfusion Systems III Feb-26-2016
41 Medtronic Perfusion Systems II Nov-12-2015
42 Medtronic Perfusion Systems II Aug-19-2015
43 Medtronic Perfusion Systems II Jun-26-2015
44 OriGen Biomedical, Inc. I Jun-04-2019
45 OriGen Biomedical, Inc. I Nov-07-2018
46 OriGen Biomedical, Inc. II Oct-18-2018
47 OriGen Biomedical, Inc. II Oct-12-2018
48 OriGen Biomedical, Inc. I Oct-20-2017
49 OriGen Biomedical, Inc. I Apr-23-2015
50 SPS Sterilization, Inc II Sep-13-2018
51 Sorin Group USA, Inc. II Nov-08-2017
52 Sorin Group USA, Inc. II Aug-10-2017
53 Sorin Group USA, Inc. II Sep-08-2016
54 Sorin Group USA, Inc. II Jul-08-2016
55 Sorin Group USA, Inc. III Feb-25-2016
56 Sorin Group USA, Inc. II Feb-16-2016
57 Sorin Group USA, Inc. II Aug-20-2013
58 Sorin Group USA, Inc. II Nov-15-2010
59 Sorin Group USA, Inc. II Jul-22-2010
60 Sorin Group USA, Inc. II Mar-12-2010
61 Surge Medical Sales, LLC (DBA Surge Cardiovascular) II Oct-04-2018
62 Terumo Cardiovascular Systems Corp II Oct-31-2014
63 Terumo Cardiovascular Systems Corporation II Jul-23-2014
64 Terumo Cardiovascular Systems Corporation II Mar-19-2014
65 Terumo Cardiovascular Systems Corporation II Nov-08-2013
66 Terumo Cardiovascular Systems Corporation II Jan-11-2013
67 Terumo Cardiovascular Systems Corporation II Dec-03-2012
68 Terumo Cardiovascular Systems Corporation II Jun-27-2012
69 Terumo Cardiovascular Systems Corporation II Jun-20-2012
70 Terumo Cardiovascular Systems Corporation II Mar-23-2012
71 Terumo Cardiovascular Systems Corporation I Jun-14-2011
72 Terumo Cardiovascular Systems Corporation II Feb-06-2009
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