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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
2
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
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
117
117
Fluid/Blood Leak
81
81
Crack
68
68
Material Puncture/Hole
66
66
Material Separation
49
49
Mechanical Problem
48
48
Detachment of Device or Device Component
47
47
Material Deformation
42
42
Break
42
42
Disconnection
39
39
Fracture
31
31
Leak/Splash
29
29
Obstruction of Flow
28
28
Packaging Problem
19
19
Nonstandard Device
17
17
Material Twisted/Bent
16
16
Insufficient Information
16
16
Material Split, Cut or Torn
16
16
Gas/Air Leak
13
13
Loss of or Failure to Bond
12
12
Difficult to Insert
11
11
Migration
11
11
Air/Gas in Device
11
11
Difficult to Remove
10
10
Defective Component
10
10
Device Markings/Labelling Problem
9
9
Device Contamination with Chemical or Other Material
8
8
Physical Resistance/Sticking
8
8
Component Missing
8
8
Material Rupture
7
7
Detachment Of Device Component
7
7
Improper Flow or Infusion
7
7
Defective Device
7
7
Deformation Due to Compressive Stress
6
6
Material Integrity Problem
6
6
Positioning Problem
6
6
Coagulation in Device or Device Ingredient
6
6
Device Slipped
6
6
Improper or Incorrect Procedure or Method
6
6
Delivered as Unsterile Product
5
5
Material Discolored
5
5
Restricted Flow rate
5
5
No Flow
5
5
Appropriate Term/Code Not Available
5
5
Split
5
5
Contamination /Decontamination Problem
4
4
Device Displays Incorrect Message
4
4
Difficult to Advance
4
4
Temperature Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Unintended Movement
4
4
Ejection Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
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
Unraveled Material
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
Contamination
3
3
Noise, Audible
3
3
Device Handling Problem
3
3
Device Operates Differently Than Expected
3
3
Free or Unrestricted Flow
3
3
Malposition of Device
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
Infusion or Flow Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Patient Device Interaction Problem
2
2
No Apparent Adverse Event
2
2
Explosion
2
2
Material Too Soft/Flexible
2
2
Separation Problem
2
2
Premature Separation
2
2
Collapse
2
2
Partial Blockage
2
2
Air Leak
2
2
Inaccurate Flow Rate
2
2
Entrapment of Device
2
2
Increase in Pressure
2
2
Suction Problem
2
2
Material Perforation
2
2
Device Damaged Prior to Use
1
1
Fitting Problem
1
1
Unknown (for use when the device problem is not known)
1
1
Device Contamination with Body Fluid
1
1
Microbial Contamination of Device
1
1
Use of Device Problem
1
1
Vibration
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
292
292
No Known Impact Or Consequence To Patient
136
136
No Consequences Or Impact To Patient
82
82
Hemorrhage/Bleeding
72
73
Blood Loss
42
42
Death
40
40
Insufficient Information
27
27
Cardiac Arrest
23
23
Hematoma
19
19
Cardiac Perforation
16
16
Air Embolism
15
15
No Patient Involvement
15
15
Thrombosis/Thrombus
14
14
Device Embedded In Tissue or Plaque
11
11
No Code Available
11
11
Perforation
11
11
Ischemia
10
10
Exsanguination
10
10
Low Blood Pressure/ Hypotension
10
10
Vascular Dissection
10
10
Cardiac Tamponade
9
9
Perforation of Vessels
9
9
Obstruction/Occlusion
7
7
Pulmonary Embolism
7
7
No Information
7
7
Foreign Body In Patient
6
6
Swelling/ Edema
6
6
Hypoxia
6
6
Respiratory Failure
6
6
Hypovolemia
6
6
Sepsis
6
6
Rupture
4
4
Bronchopneumonia
4
4
Aortic Dissection
4
4
Unspecified Infection
4
4
Hemolysis
4
4
Laceration(s)
4
4
Embolism
4
4
Bradycardia
4
4
Stroke/CVA
4
4
Arrhythmia
3
3
Vascular System (Circulation), Impaired
3
3
Low Oxygen Saturation
3
3
Decreased Respiratory Rate
3
3
Tissue Damage
3
3
Venipuncture
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
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
Airway Obstruction
2
2
Bacterial Infection
2
2
Cardiopulmonary Arrest
2
2
Pneumothorax
2
2
Extravasation
2
2
Hyperbilirubinemia
1
1
High Blood Pressure/ Hypertension
1
1
Pulmonary Dysfunction
1
1
Pneumonia
1
1
Neurological Deficit/Dysfunction
1
1
Pain
1
1
Chest Pain
1
1
Contusion
1
1
Endocarditis
1
1
Dyspnea
1
1
Myocardial Contusion
1
1
Aortic Valve Stenosis
1
1
Atrial Flutter
1
1
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
Heart Failure/Congestive Heart Failure
1
1
Unspecified Heart Problem
1
1
Cough
1
1
Respiratory Arrest
1
1
Gastrointestinal Hemorrhage
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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