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TPLC
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Device
catheter, oximeter, fiber-optic
Product Code
DQE
Regulation Number
870.1230
Device Class
2
Premarket Reviews
Manufacturer
Decision
EDWARDS LIFESCIENCE LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
68
68
2017
47
47
2018
38
38
2019
63
63
2020
39
39
2021
39
39
2022
57
57
2023
52
52
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
108
108
Material Rupture
69
69
Incorrect Measurement
38
38
Leak/Splash
35
35
Adverse Event Without Identified Device or Use Problem
24
24
Fluid/Blood Leak
18
18
Appropriate Term/Code Not Available
13
13
Deflation Problem
12
12
Difficult to Insert
12
12
Material Separation
11
11
Material Split, Cut or Torn
11
11
Inflation Problem
11
11
Output Problem
9
9
Break
9
9
Unable to Obtain Readings
8
8
Kinked
7
7
Material Fragmentation
7
7
Device Contamination with Chemical or Other Material
7
7
Detachment of Device or Device Component
6
6
Positioning Problem
5
5
Difficult to Remove
5
5
Detachment Of Device Component
4
4
Device Operates Differently Than Expected
4
4
Physical Resistance/Sticking
4
4
Difficult to Advance
3
3
Malposition of Device
3
3
Defective Device
2
2
Device Displays Incorrect Message
2
2
High Test Results
2
2
Low Readings
2
2
Failure to Advance
2
2
Insufficient Flow or Under Infusion
2
2
Microbial Contamination of Device
2
2
Contamination /Decontamination Problem
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Crack
2
2
Display or Visual Feedback Problem
2
2
Burst Container or Vessel
2
2
Device Alarm System
2
2
Increase in Pressure
2
2
Knotted
2
2
No Device Output
2
2
Temperature Problem
2
2
Unintended Movement
2
2
Insufficient Information
2
2
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Failure to Deflate
1
1
Component Misassembled
1
1
Overheating of Device
1
1
Pacing Problem
1
1
Peeled/Delaminated
1
1
Looping
1
1
Material Puncture/Hole
1
1
Poor Quality Image
1
1
Retraction Problem
1
1
Backflow
1
1
Calibration Error
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
No Display/Image
1
1
False Reading From Device Non-Compliance
1
1
Inaccurate Flow Rate
1
1
Material Frayed
1
1
Hole In Material
1
1
Activation, Positioning or Separation Problem
1
1
Protective Measures Problem
1
1
No Pressure
1
1
Output below Specifications
1
1
Device Dislodged or Dislocated
1
1
Gas/Air Leak
1
1
Human-Device Interface Problem
1
1
Infusion or Flow Problem
1
1
Component Missing
1
1
Obstruction of Flow
1
1
Inadequacy of Device Shape and/or Size
1
1
Device Inoperable
1
1
Unstable
1
1
Failure to Zero
1
1
Improper or Incorrect Procedure or Method
1
1
Physical Resistance
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
189
189
No Clinical Signs, Symptoms or Conditions
119
119
No Known Impact Or Consequence To Patient
72
72
Hemorrhage/Bleeding
10
10
No Patient Involvement
8
8
No Code Available
7
7
Insufficient Information
7
7
No Information
5
5
Blood Loss
5
5
Cardiac Perforation
5
5
Hypersensitivity/Allergic reaction
4
4
Perforation
4
4
Foreign Body In Patient
4
4
Shaking/Tremors
3
3
Low Blood Pressure/ Hypotension
3
3
Unspecified Infection
3
4
Congenital Defect/Deformity
3
3
Hemothorax
2
2
Fever
2
2
Hematoma
2
2
Injury
2
2
Perforation of Vessels
2
2
Chills
2
2
Respiratory Distress
2
2
Thrombus
2
2
Patient Problem/Medical Problem
2
2
Cardiac Arrest
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Ectopic Heartbeat
1
1
Alteration In Body Temperature
1
1
Device Embedded In Tissue or Plaque
1
1
Tricuspid Regurgitation
1
1
Ventricular Fibrillation
1
1
Thrombosis
1
1
Pneumonia
1
1
Pneumothorax
1
1
High Blood Pressure/ Hypertension
1
1
Stenosis
1
1
Reaction
1
1
Needle Stick/Puncture
1
1
Hemoptysis
1
1
Infiltration into Tissue
1
1
Mitral Valve Stenosis
1
1
Necrosis
1
1
Death
1
1
Dyspnea
1
1
Embolism
1
1
Encephalopathy
1
1
Angina
1
1
Aortic Insufficiency
1
1
Aortic Valve Stenosis
1
1
Arrhythmia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
II
Aug-12-2021
2
Edwards Lifesciences, LLC
II
Jul-10-2020
3
ICU Medical, Inc.
II
May-14-2020
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