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TPLC
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Device
catheter, flow directed
Product Code
DYG
Regulation Number
870.1240
Device Class
2
Premarket Reviews
Manufacturer
Decision
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCESS LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
115
115
2018
133
133
2019
144
144
2020
104
104
2021
97
97
2022
130
130
2023
227
227
2024
50
50
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
137
137
Pacing Problem
91
91
Incorrect Measurement
87
87
Inflation Problem
86
86
Incorrect, Inadequate or Imprecise Result or Readings
84
84
Deflation Problem
75
75
Adverse Event Without Identified Device or Use Problem
54
54
Leak/Splash
47
47
Appropriate Term/Code Not Available
38
38
Failure to Capture
33
33
Difficult to Advance
32
32
Material Separation
28
28
Break
24
24
Burst Container or Vessel
23
23
Material Split, Cut or Torn
22
22
Physical Resistance/Sticking
22
22
Detachment of Device or Device Component
21
21
Difficult to Remove
16
16
No Pacing
15
15
Fluid/Blood Leak
15
15
Material Deformation
12
12
Material Puncture/Hole
12
12
No Device Output
11
11
Failure to Deflate
9
9
Defective Device
9
9
Component Missing
9
9
Difficult or Delayed Positioning
8
8
Material Integrity Problem
8
8
Unable to Obtain Readings
8
8
Difficult to Insert
8
8
Entrapment of Device
6
6
Output Problem
6
6
Detachment Of Device Component
6
6
Material Fragmentation
6
6
Material Twisted/Bent
6
6
Obstruction of Flow
6
6
Activation, Positioning or Separation Problem
6
6
Failure to Advance
5
5
Defective Component
5
5
Patient-Device Incompatibility
4
4
Use of Device Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Activation Failure
4
4
Connection Problem
4
4
Inaccurate Information
4
4
Temperature Problem
4
4
Insufficient Information
4
4
Insufficient Flow or Under Infusion
4
4
Malposition of Device
3
3
Flaked
3
3
Mechanical Problem
3
3
Crack
3
3
Unintended Movement
3
3
Device Contamination with Chemical or Other Material
3
3
Device Displays Incorrect Message
3
3
High Test Results
3
3
Failure to Calibrate
3
3
Difficult to Flush
3
3
Gas/Air Leak
3
3
Contamination
3
3
Product Quality Problem
3
3
Tear, Rip or Hole in Device Packaging
2
2
Data Problem
2
2
Pacing Inadequately
2
2
Device Operates Differently Than Expected
2
2
Signal Artifact/Noise
2
2
Capturing Problem
2
2
Device Dislodged or Dislocated
2
2
High Readings
2
2
Air Leak
2
2
Complete Blockage
2
2
Material Protrusion/Extrusion
2
2
Separation Problem
2
2
Device Alarm System
2
2
Disconnection
2
2
Kinked
1
1
Loose or Intermittent Connection
1
1
Device Markings/Labelling Problem
1
1
Device Damaged Prior to Use
1
1
Difficult or Delayed Activation
1
1
Packaging Problem
1
1
Display or Visual Feedback Problem
1
1
Nonstandard Device
1
1
Device Or Device Fragments Location Unknown
1
1
Calibration Problem
1
1
Inaccurate Delivery
1
1
Protective Measures Problem
1
1
Device Handling Problem
1
1
Excess Flow or Over-Infusion
1
1
Pacing Intermittently
1
1
Unsealed Device Packaging
1
1
Off-Label Use
1
1
Unclear Information
1
1
Device Contaminated During Manufacture or Shipping
1
1
Inadequacy of Device Shape and/or Size
1
1
Low Test Results
1
1
Pressure Problem
1
1
Backflow
1
1
Coagulation in Device or Device Ingredient
1
1
Delivered as Unsterile Product
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
400
400
No Consequences Or Impact To Patient
314
314
No Known Impact Or Consequence To Patient
165
165
Insufficient Information
54
54
No Patient Involvement
23
23
Vascular Dissection
15
15
No Code Available
13
13
Hemorrhage/Bleeding
13
13
Arrhythmia
11
11
Cardiac Tamponade
10
10
No Information
9
9
Low Blood Pressure/ Hypotension
8
8
Foreign Body In Patient
8
8
Death
7
7
Cardiac Perforation
7
7
Great Vessel Perforation
7
7
Device Embedded In Tissue or Plaque
7
7
Cardiac Arrest
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Bradycardia
5
5
Hypersensitivity/Allergic reaction
4
4
Pain
4
4
Needle Stick/Puncture
4
4
Chest Pain
3
3
Atrial Fibrillation
3
3
High Blood Pressure/ Hypertension
3
3
Dyspnea
3
3
Anaphylactic Shock
3
3
Complaint, Ill-Defined
3
3
Pericardial Effusion
3
3
Aortic Valve Stenosis
3
3
Perforation of Vessels
3
3
Extravasation
2
2
Failure of Implant
2
2
Dyskinesia
2
2
Reaction
2
2
Hemoptysis
2
2
Pulmonary Embolism
2
2
Edema
2
2
Myocardial Infarction
2
2
Tingling
2
2
Swelling/ Edema
2
2
Low Oxygen Saturation
2
2
Renal Failure
2
2
Anaphylactoid
2
2
Perforation
2
2
Unspecified Vascular Problem
2
2
Rupture
2
2
Unspecified Infection
2
2
Left Ventricular Dysfunction
1
1
Headache
1
1
Blood Loss
1
1
Valvular Stenosis
1
1
Pneumothorax
1
1
Injury
1
1
Thrombus
1
1
Air Embolism
1
1
Aneurysm
1
1
Autoimmune Reaction
1
1
Cardiopulmonary Arrest
1
1
Fever
1
1
Loss of consciousness
1
1
Pseudoaneurysm
1
1
Ectopic Heartbeat
1
1
Necrosis
1
1
Atrial Flutter
1
1
Paresis
1
1
Septic Shock
1
1
Physical Entrapment
1
1
Complete Heart Block
1
1
Shock
1
1
Tissue Damage
1
1
Vascular System (Circulation), Impaired
1
1
Foreign Body Reaction
1
1
Exposure to Body Fluids
1
1
Sepsis
1
1
Therapeutic Effects, Unexpected
1
1
Anemia
1
1
Non specific EKG/ECG Changes
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Dec-19-2019
2
Edwards Lifesciences, LLC
II
Apr-12-2023
3
Edwards Lifesciences, LLC
I
Jan-31-2019
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