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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
Regulation Description Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Product CodeDWF
Regulation Number 870.4210
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIOGARD MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
KAPP SURGICAL INSTRUMENT, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIVANOVA USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
  1.  K190557  Bio-Medicus Insertion Kit
  2.  K201100  Bio-Medicus Life Support Catheter and Introducer
  3.  K230960  DLP™ Silicone Coronary Artery Ostial Cannulae
  4.  K231206  DLP Silicone Coronary Artery Ostial Cannulae
  5.  K251258  MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage V ...
  6.  K253203  Retrograde Coronary Sinus Perfusion Cannulae
  7.  K253998  Clearview Intracoronary Shunts
  8.  K260195  Elongated One-Piece Arterial (EOPA) 3D™ Arterial C ...
QURA S.R.L
  SUBSTANTIALLY EQUIVALENT 4
SMART REACTORS
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 4
SPECTRUM MEDICAL S.R.L.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 179 180
2020 142 143
2021 162 162
2022 276 277
2023 470 482
2024 401 401
2025 1031 1031
2026 427 427

Device Problems MDRs with this Device Problem Events in those MDRs
Material Separation 551 551
Mechanical Problem 390 390
Material Deformation 378 381
Fluid/Blood Leak 299 303
Crack 246 255
Delivered as Unsterile Product 236 236
Material Puncture/Hole 218 219
Adverse Event Without Identified Device or Use Problem 187 187
Contamination 181 181
Obstruction of Flow 155 157
Break 96 96
Misassembled During Installation 74 74
Detachment of Device or Device Component 65 66
Air/Gas in Device 60 60
Packaging Problem 58 58
Device Markings/Labelling Problem 56 56
Disconnection 46 46
Leak/Splash 43 43
Fracture 43 43
Difficult to Open or Close 38 38
Insufficient Information 32 32
Component Missing 30 30
Material Twisted/Bent 28 28
Material Split, Cut or Torn 21 21
Manufacturing, Packaging or Shipping Problem 21 21
Loss of or Failure to Bond 18 18
Material Integrity Problem 18 18
Nonstandard Device 17 17
Material Rupture 15 15
Gas/Air Leak 13 13
Migration 13 13
Defective Component 12 12
Increase in Pressure 11 11
Difficult to Insert 11 11
Deformation Due to Compressive Stress 10 10
Improper Flow or Infusion 9 9
Use of Device Problem 9 9
Infusion or Flow Problem 8 8
Positioning Problem 8 8
No Flow 7 7
Partial Blockage 7 7
Tear, Rip or Hole in Device Packaging 7 7
Contamination /Decontamination Problem 7 7
Device Contamination with Chemical or Other Material 7 7
Defective Device 7 7
Appropriate Term/Code Not Available 7 7
Restricted Flow rate 7 7
Physical Resistance/Sticking 7 7
Ejection Problem 6 6
Unsealed Device Packaging 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2311 2322
Hemorrhage/Bleeding 227 230
No Known Impact Or Consequence To Patient 111 111
Insufficient Information 80 81
No Consequences Or Impact To Patient 57 57
Blood Loss 36 37
Perforation of Vessels 33 33
Cardiac Arrest 32 32
Stroke/CVA 29 29
Death 28 28
Foreign Body In Patient 23 23
Air Embolism 22 22
Low Blood Pressure/ Hypotension 22 22
Thrombosis/Thrombus 20 20
Ischemia 19 19
Exsanguination 19 19
Hematoma 18 18
Perforation 16 16
Vascular Dissection 16 16
Renal Failure 15 15
Cardiac Perforation 14 14
Cardiac Tamponade 13 13
Unspecified Infection 13 13
Sepsis 13 13
No Patient Involvement 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Device Embedded In Tissue or Plaque 11 11
Atrial Fibrillation 10 10
Swelling/ Edema 9 9
Unspecified Tissue Injury 8 8
Hemolysis 8 8
Obstruction/Occlusion 8 8
Hypoxia 7 7
Respiratory Failure 7 7
Bradycardia 6 6
Arrhythmia 6 6
Pericardial Effusion 6 6
Pulmonary Embolism 6 6
Hypovolemia 6 6
Myocardial Infarction 5 5
Laceration(s) 5 5
Rupture 5 5
Ischemia Stroke 5 5
Pulmonary Edema 4 4
Pneumonia 4 4
Convulsion/Seizure 4 4
Bacterial Infection 4 4
Cardiogenic Shock 4 4
Decreased Respiratory Rate 4 4
Pleural Effusion 4 4

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 Cardiovascular, LLC II May-31-2019
8 Medtronic Perfusion Systems I Sep-03-2025
9 Medtronic Perfusion Systems I Mar-13-2025
10 Medtronic Perfusion Systems II Jan-17-2025
11 Medtronic Perfusion Systems II Nov-04-2024
12 Medtronic Perfusion Systems II Sep-12-2024
13 Medtronic Perfusion Systems II May-10-2024
14 Medtronic Perfusion Systems II Mar-19-2024
15 Medtronic Perfusion Systems II Jan-12-2022
16 Medtronic Perfusion Systems II Oct-01-2021
17 Medtronic Perfusion Systems II Jun-16-2021
18 OriGen Biomedical, Inc. I Jun-04-2019
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