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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
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
93
93
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
121
121
Crack
94
94
Fluid/Blood Leak
91
91
Material Deformation
82
82
Material Puncture/Hole
80
80
Mechanical Problem
55
55
Material Separation
50
50
Detachment of Device or Device Component
50
50
Break
43
43
Disconnection
40
40
Fracture
34
34
Obstruction of Flow
34
34
Leak/Splash
32
32
Material Twisted/Bent
22
22
Packaging Problem
21
21
Material Split, Cut or Torn
18
18
Insufficient Information
17
17
Nonstandard Device
17
17
Loss of or Failure to Bond
14
14
Gas/Air Leak
14
14
Air/Gas in Device
13
13
Migration
11
11
Difficult to Insert
11
11
Difficult to Remove
10
10
Defective Component
10
10
Component Missing
10
10
Device Markings/Labelling Problem
10
10
Physical Resistance/Sticking
9
9
Device Contamination with Chemical or Other Material
8
8
Improper Flow or Infusion
7
7
Defective Device
7
7
Material Integrity Problem
7
7
Material Rupture
7
7
Detachment Of Device Component
7
7
Coagulation in Device or Device Ingredient
6
6
Device Slipped
6
6
Improper or Incorrect Procedure or Method
6
6
No Flow
6
6
Positioning Problem
6
6
Ejection Problem
6
6
Deformation Due to Compressive Stress
6
6
Split
5
5
Appropriate Term/Code Not Available
5
5
Delivered as Unsterile Product
5
5
Material Discolored
5
5
Restricted Flow rate
5
5
Inflation Problem
4
4
Loose or Intermittent Connection
4
4
Unsealed Device Packaging
4
4
Material Too Rigid or Stiff
4
4
Insufficient Flow or Under Infusion
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
Difficult to Advance
4
4
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
Misassembled During Installation
3
3
Unraveled Material
3
3
Increase in Pressure
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
Material Too Soft/Flexible
3
3
Collapse
2
2
Air Leak
2
2
Inaccurate Flow Rate
2
2
Entrapment of Device
2
2
Suction Problem
2
2
Material Perforation
2
2
Separation Problem
2
2
Premature Separation
2
2
Patient Device Interaction Problem
2
2
Explosion
2
2
No Apparent Adverse Event
2
2
Infusion or Flow Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Human-Device Interface Problem
1
1
Aspiration Issue
1
1
Device Operational Issue
1
1
Device Packaging Compromised
1
1
Device Sensing Problem
1
1
Device-Device Incompatibility
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
367
367
No Known Impact Or Consequence To Patient
136
136
Hemorrhage/Bleeding
85
86
No Consequences Or Impact To Patient
82
82
Blood Loss
42
42
Death
40
40
Insufficient Information
29
29
Cardiac Arrest
23
23
Hematoma
19
19
Cardiac Perforation
16
16
Air Embolism
15
15
Thrombosis/Thrombus
15
15
No Patient Involvement
15
15
Exsanguination
13
13
Perforation
11
11
Device Embedded In Tissue or Plaque
11
11
No Code Available
11
11
Vascular Dissection
10
10
Ischemia
10
10
Low Blood Pressure/ Hypotension
10
10
Cardiac Tamponade
10
10
Perforation of Vessels
10
10
Obstruction/Occlusion
8
8
Pulmonary Embolism
7
7
No Information
7
7
Foreign Body In Patient
7
7
Swelling/ Edema
6
6
Hypoxia
6
6
Respiratory Failure
6
6
Hypovolemia
6
6
Sepsis
6
6
Unspecified Infection
5
5
Hemolysis
5
5
Laceration(s)
4
4
Stroke/CVA
4
4
Embolism
4
4
Bacterial Infection
4
4
Bradycardia
4
4
Rupture
4
4
Bronchopneumonia
4
4
Aortic Dissection
4
4
Vascular System (Circulation), Impaired
3
3
Low Oxygen Saturation
3
3
Decreased Respiratory Rate
3
3
Tissue Damage
3
3
Venipuncture
3
3
Arrhythmia
3
3
Endocarditis
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Patient Problem/Medical Problem
3
3
Multiple Organ Failure
3
3
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
Cardiopulmonary Arrest
2
2
Airway Obstruction
2
2
Pneumothorax
2
2
Extravasation
2
2
Pulmonary Edema
2
2
Non specific EKG/ECG Changes
2
2
Thrombus
2
2
Sudden Cardiac Death
2
2
Atrial Perforation
2
2
Brain Injury
2
2
Excessive Tear Production
1
1
Ulcer
1
1
Hemolytic Anemia
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
Heart Failure
1
1
Hyperbilirubinemia
1
1
High Blood Pressure/ Hypertension
1
1
Pulmonary Dysfunction
1
1
Pneumonia
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Aortic Valve Stenosis
1
1
Atrial Flutter
1
1
Myocardial Contusion
1
1
Chest Pain
1
1
Contusion
1
1
Dyspnea
1
1
Heart Failure/Congestive Heart Failure
1
1
Unspecified Heart Problem
1
1
Cough
1
1
Respiratory Arrest
1
1
Respiratory Insufficiency
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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