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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
Fluid/Blood Leak
15
15
No Pacing
15
15
Material Deformation
12
12
Material Puncture/Hole
12
12
No Device Output
11
11
Component Missing
9
9
Defective Device
9
9
Failure to Deflate
9
9
Material Integrity Problem
8
8
Unable to Obtain Readings
8
8
Difficult to Insert
8
8
Difficult or Delayed Positioning
8
8
Detachment Of Device Component
6
6
Entrapment of Device
6
6
Material Fragmentation
6
6
Obstruction of Flow
6
6
Material Twisted/Bent
6
6
Output Problem
6
6
Activation, Positioning or Separation Problem
6
6
Failure to Advance
5
5
Defective Component
5
5
Use of Device Problem
4
4
Insufficient Flow or Under Infusion
4
4
Connection Problem
4
4
Patient-Device Incompatibility
4
4
Temperature Problem
4
4
Therapeutic or Diagnostic Output Failure
4
4
Insufficient Information
4
4
Activation Failure
4
4
Inaccurate Information
4
4
Unintended Movement
3
3
Device Contamination with Chemical or Other Material
3
3
Gas/Air Leak
3
3
Device Displays Incorrect Message
3
3
Malposition of Device
3
3
Failure to Calibrate
3
3
High Test Results
3
3
Product Quality Problem
3
3
Mechanical Problem
3
3
Flaked
3
3
Difficult to Flush
3
3
Contamination
3
3
Crack
3
3
Disconnection
2
2
Complete Blockage
2
2
Air Leak
2
2
Device Alarm System
2
2
Signal Artifact/Noise
2
2
Pacing Inadequately
2
2
Tear, Rip or Hole in Device Packaging
2
2
High Readings
2
2
Capturing Problem
2
2
Device Dislodged or Dislocated
2
2
Device Operates Differently Than Expected
2
2
Material Protrusion/Extrusion
2
2
Separation Problem
2
2
Data Problem
2
2
Device Handling Problem
1
1
Unclear Information
1
1
Unintended Deflation
1
1
Device Contaminated During Manufacture or Shipping
1
1
No Apparent Adverse Event
1
1
Packaging Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Contamination /Decontamination Problem
1
1
Communication or Transmission Problem
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Device Ingredient or Reagent Problem
1
1
Device Markings/Labelling Problem
1
1
Low Readings
1
1
Structural Problem
1
1
Difficult or Delayed Activation
1
1
Device Or Device Fragments Location Unknown
1
1
Device Contamination with Body Fluid
1
1
Inaccurate Delivery
1
1
Low Test Results
1
1
Device Damaged Prior to Use
1
1
Improper or Incorrect Procedure or Method
1
1
Shipping Damage or Problem
1
1
Inadequacy of Device Shape and/or Size
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
Foreign Body In Patient
8
8
Low Blood Pressure/ Hypotension
8
8
Death
7
7
Cardiac Perforation
7
7
Device Embedded In Tissue or Plaque
7
7
Great Vessel Perforation
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
Complaint, Ill-Defined
3
3
Perforation of Vessels
3
3
Pericardial Effusion
3
3
High Blood Pressure/ Hypertension
3
3
Dyspnea
3
3
Chest Pain
3
3
Aortic Valve Stenosis
3
3
Atrial Fibrillation
3
3
Anaphylactic Shock
3
3
Pulmonary Embolism
2
2
Edema
2
2
Extravasation
2
2
Hemoptysis
2
2
Failure of Implant
2
2
Unspecified Infection
2
2
Myocardial Infarction
2
2
Perforation
2
2
Unspecified Vascular Problem
2
2
Low Oxygen Saturation
2
2
Dyskinesia
2
2
Reaction
2
2
Tingling
2
2
Rupture
2
2
Anaphylactoid
2
2
Renal Failure
2
2
Swelling/ Edema
2
2
Sepsis
1
1
Septic Shock
1
1
Shock
1
1
Therapeutic Effects, Unexpected
1
1
Thrombus
1
1
Tissue Damage
1
1
Loss of consciousness
1
1
Injury
1
1
Physical Entrapment
1
1
Ectopic Heartbeat
1
1
Vascular System (Circulation), Impaired
1
1
Blood Loss
1
1
Pseudoaneurysm
1
1
Complete Heart Block
1
1
Valvular Stenosis
1
1
Pneumothorax
1
1
Paresis
1
1
Necrosis
1
1
Left Ventricular Dysfunction
1
1
Non specific EKG/ECG Changes
1
1
Fever
1
1
Foreign Body Reaction
1
1
Headache
1
1
Cardiopulmonary Arrest
1
1
Air Embolism
1
1
Anemia
1
1
Aneurysm
1
1
Atrial Flutter
1
1
Autoimmune Reaction
1
1
Exposure to Body Fluids
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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