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TPLC
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Device
catheter, cannula and tubing, vascular, cardiopulmonary bypass
Product Code
DWF
Regulation Number
870.4210
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANGIODYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
2
CARDIOGARD MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES
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
3
QURA S.R.L.
SUBSTANTIALLY EQUIVALENT
4
SORIN GROUP ITALIA S.R.L.
SUBSTANTIALLY EQUIVALENT
2
SPECTRUM MEDICAL S.R.L.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
178
178
2020
142
142
2021
162
162
2022
276
276
2023
471
471
2024
155
155
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Deformation
188
188
Mechanical Problem
161
161
Fluid/Blood Leak
148
148
Material Puncture/Hole
146
146
Crack
141
141
Adverse Event Without Identified Device or Use Problem
133
133
Material Separation
101
101
Obstruction of Flow
58
58
Break
54
54
Detachment of Device or Device Component
46
46
Disconnection
42
42
Leak/Splash
40
40
Fracture
38
38
Insufficient Information
26
26
Material Twisted/Bent
25
25
Packaging Problem
24
24
Air/Gas in Device
22
22
Material Split, Cut or Torn
19
19
Loss of or Failure to Bond
18
18
Nonstandard Device
17
17
Migration
13
13
Gas/Air Leak
13
13
Misassembled During Installation
12
12
Difficult to Insert
11
11
Contamination
10
10
Device Markings/Labelling Problem
10
10
Improper Flow or Infusion
9
9
Defective Component
9
9
Component Missing
8
8
Material Rupture
8
8
Increase in Pressure
7
7
Defective Device
7
7
Deformation Due to Compressive Stress
7
7
Device Contamination with Chemical or Other Material
7
7
Infusion or Flow Problem
6
6
No Flow
6
6
Material Integrity Problem
6
6
Ejection Problem
6
6
Physical Resistance/Sticking
6
6
Coagulation in Device or Device Ingredient
6
6
Loose or Intermittent Connection
6
6
Unsealed Device Packaging
5
5
Restricted Flow rate
5
5
Positioning Failure
5
5
Material Discolored
5
5
Malposition of Device
5
5
Improper or Incorrect Procedure or Method
5
5
Manufacturing, Packaging or Shipping Problem
5
5
Appropriate Term/Code Not Available
5
5
Device Handling Problem
5
5
Positioning Problem
5
5
Therapeutic or Diagnostic Output Failure
4
4
Unintended Movement
4
4
Difficult to Remove
4
4
Contamination /Decontamination Problem
4
4
Tear, Rip or Hole in Device Packaging
4
4
Partial Blockage
4
4
Inflation Problem
4
4
Delivered as Unsterile Product
4
4
Backflow
3
3
Burst Container or Vessel
3
3
Complete Blockage
3
3
Connection Problem
3
3
Use of Device Problem
3
3
Off-Label Use
3
3
Device Slipped
3
3
No Apparent Adverse Event
3
3
Free or Unrestricted Flow
3
3
Difficult to Advance
3
3
Patient Device Interaction Problem
3
3
Material Too Soft/Flexible
3
3
Separation Problem
2
2
Premature Separation
2
2
Device Dislodged or Dislocated
2
2
Explosion
2
2
Protective Measures Problem
2
2
Unraveled Material
2
2
Inadequacy of Device Shape and/or Size
2
2
Insufficient Flow or Under Infusion
2
2
Product Quality Problem
2
2
Material Too Rigid or Stiff
2
2
Device Displays Incorrect Message
2
2
Failure to Advance
2
2
Collapse
2
2
Decoupling
2
2
Deflation Problem
2
2
Entrapment of Device
2
2
Particulates
2
2
Device Difficult to Setup or Prepare
2
2
Inaccurate Flow Rate
2
2
Material Fragmentation
2
2
Gel Leak
1
1
Incorrect Measurement
1
1
Melted
1
1
Misassembled
1
1
Material Erosion
1
1
Display or Visual Feedback Problem
1
1
Dent in Material
1
1
Failure to Disconnect
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
795
795
Hemorrhage/Bleeding
123
123
No Known Impact Or Consequence To Patient
111
111
No Consequences Or Impact To Patient
57
57
Blood Loss
36
36
Insufficient Information
34
34
Death
27
27
Cardiac Arrest
25
25
Perforation of Vessels
22
22
Exsanguination
18
18
Thrombosis/Thrombus
18
18
Hematoma
16
16
Low Blood Pressure/ Hypotension
15
15
Air Embolism
14
14
Ischemia
13
13
Cardiac Perforation
12
12
Cardiac Tamponade
11
11
No Patient Involvement
11
11
Device Embedded In Tissue or Plaque
10
10
Perforation
10
10
Vascular Dissection
9
9
Swelling/ Edema
8
8
Obstruction/Occlusion
8
8
Sepsis
7
7
Unspecified Infection
7
7
Foreign Body In Patient
7
7
Hemolysis
6
6
Bradycardia
6
6
Stroke/CVA
6
6
Hypovolemia
6
6
Respiratory Failure
6
6
Rupture
5
5
Pulmonary Embolism
5
5
Hypoxia
5
5
Laceration(s)
4
4
Bacterial Infection
4
4
Brain Injury
4
4
Bronchopneumonia
4
4
Decreased Respiratory Rate
4
4
No Code Available
4
4
Multiple Organ Failure
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Tricuspid Valve Insufficiency/ Regurgitation
4
4
Pulmonary Hypertension
3
3
Unspecified Tissue Injury
3
3
Low Oxygen Saturation
3
3
Venipuncture
3
3
Pulmonary Edema
3
3
Pneumothorax
2
2
Aortic Dissection
2
2
Sudden Cardiac Death
2
2
Atrial Perforation
2
2
Airway Obstruction
2
2
Arrhythmia
2
2
Cardiopulmonary Arrest
2
2
Non specific EKG/ECG Changes
2
2
Endocarditis
2
2
Pain
2
2
Extravasation
2
2
Foreign Body Reaction
2
2
Pericardial Effusion
2
2
Patient Problem/Medical Problem
2
2
Asystole
2
2
Hemorrhagic Stroke
2
2
Ischemia Stroke
2
2
Thrombocytopenia
2
2
Embolism/Embolus
2
2
Heart Failure/Congestive Heart Failure
1
1
Pulmonary Valve Insufficiency/ Regurgitation
1
1
Thromboembolism
1
1
Convulsion/Seizure
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
1
1
Gastrointestinal Hemorrhage
1
1
Renal Impairment
1
1
Skin Infection
1
1
Unspecified Heart Problem
1
1
Cough
1
1
Intracranial Hemorrhage
1
1
Hyperbilirubinemia
1
1
High Blood Pressure/ Hypertension
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Neurological Deficit/Dysfunction
1
1
Failure of Implant
1
1
Dyspnea
1
1
Chest Pain
1
1
Atrial Flutter
1
1
Aneurysm
1
1
Myocardial Contusion
1
1
Vascular System (Circulation), Impaired
1
1
Diminished Pulse Pressure
1
1
Complete Heart Block
1
1
Ventricular Fibrillation
1
1
Ventricular Tachycardia
1
1
Blurred Vision
1
1
Tingling
1
1
Pulmonary Dysfunction
1
1
Renal Failure
1
1
Scar Tissue
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 Cardiovascular, LLC
II
May-31-2019
8
Medtronic Perfusion Systems
II
May-10-2024
9
Medtronic Perfusion Systems
II
Mar-19-2024
10
Medtronic Perfusion Systems
II
Jan-12-2022
11
Medtronic Perfusion Systems
II
Oct-01-2021
12
Medtronic Perfusion Systems
II
Jun-16-2021
13
OriGen Biomedical, Inc.
I
Jun-04-2019
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