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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
66
66
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Rupture
137
137
Pacing Problem
93
93
Incorrect Measurement
88
88
Inflation Problem
87
87
Incorrect, Inadequate or Imprecise Result or Readings
84
84
Deflation Problem
76
76
Adverse Event Without Identified Device or Use Problem
54
54
Leak/Splash
47
47
Appropriate Term/Code Not Available
38
38
Difficult to Advance
33
33
Failure to Capture
33
33
Material Separation
28
28
Burst Container or Vessel
25
25
Break
24
24
Detachment of Device or Device Component
22
22
Material Split, Cut or Torn
22
22
Physical Resistance/Sticking
22
22
Fluid/Blood Leak
16
16
Difficult to Remove
16
16
No Pacing
15
15
Material Deformation
12
12
Material Puncture/Hole
12
12
No Device Output
11
11
Failure to Deflate
11
11
Difficult to Insert
10
10
Component Missing
9
9
Defective Device
9
9
Material Integrity Problem
8
8
Unable to Obtain Readings
8
8
Difficult or Delayed Positioning
8
8
Material Fragmentation
7
7
Entrapment of Device
6
6
Detachment Of Device Component
6
6
Obstruction of Flow
6
6
Output Problem
6
6
Activation, Positioning or Separation Problem
6
6
Material Twisted/Bent
6
6
Insufficient Information
5
5
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
Gas/Air Leak
4
4
Activation Failure
4
4
Inaccurate Information
4
4
Device Contamination with Chemical or Other Material
3
3
Unintended Movement
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
Contamination
3
3
Crack
3
3
Flaked
3
3
Difficult to Flush
3
3
Mechanical Problem
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 Operates Differently Than Expected
2
2
Device Dislodged or Dislocated
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
414
414
No Consequences Or Impact To Patient
314
314
No Known Impact Or Consequence To Patient
165
165
Insufficient Information
55
55
No Patient Involvement
23
23
Vascular Dissection
15
15
Hemorrhage/Bleeding
14
14
No Code Available
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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