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TPLC
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Device
transducer, pressure, catheter tip
Product Code
DXO
Regulation Number
870.2870
Device Class
2
Premarket Reviews
Manufacturer
Decision
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFECIENCES, LLC
SUBSTANTIALLY EQUIVALENT
1
EDWARDS LIFESCIENCES LLC
SUBSTANTIALLY EQUIVALENT
1
OPSENS INC
SUBSTANTIALLY EQUIVALENT
1
OPSENS INC.
SUBSTANTIALLY EQUIVALENT
2
ZURICH MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
153
153
2020
158
158
2021
116
116
2022
144
144
2023
194
194
2024
64
64
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
159
159
Detachment of Device or Device Component
144
144
Communication or Transmission Problem
82
82
Material Separation
57
57
Incorrect Measurement
50
50
Contamination
50
50
Break
40
40
Failure to Advance
39
39
Device Contamination with Chemical or Other Material
38
38
Adverse Event Without Identified Device or Use Problem
34
34
Difficult to Remove
33
33
Fracture
29
29
Failure to Zero
24
24
Fluid/Blood Leak
23
23
Leak/Splash
22
22
Improper or Incorrect Procedure or Method
19
19
Contamination /Decontamination Problem
19
19
Material Deformation
18
18
Difficult to Advance
17
17
Material Integrity Problem
14
14
Use of Device Problem
14
14
Deformation Due to Compressive Stress
13
13
Disconnection
12
12
Entrapment of Device
10
10
Physical Resistance/Sticking
10
10
Material Split, Cut or Torn
9
9
Output Problem
8
8
Device Contaminated During Manufacture or Shipping
7
7
Inaccurate Flow Rate
7
7
Loose or Intermittent Connection
6
6
Mechanical Problem
6
6
Unsealed Device Packaging
6
6
Defective Device
6
6
Calibration Problem
5
5
Peeled/Delaminated
5
5
Stretched
5
5
Air/Gas in Device
5
5
Failure to Clean Adequately
4
4
Positioning Problem
4
4
Material Twisted/Bent
4
4
Mechanical Jam
4
4
Contamination of Device Ingredient or Reagent
3
3
Defective Component
3
3
Flushing Problem
3
3
Crack
3
3
Insufficient Information
3
3
Appropriate Term/Code Not Available
3
3
Inaccurate Information
3
3
Therapeutic or Diagnostic Output Failure
2
2
Improper Flow or Infusion
2
2
Infusion or Flow Problem
2
2
Material Discolored
2
2
No Display/Image
2
2
Display or Visual Feedback Problem
2
2
Pacing Problem
2
2
Unable to Obtain Readings
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Sensing Problem
2
2
Device Damaged Prior to Use
2
2
Connection Problem
2
2
Activation, Positioning or Separation Problem
1
1
No Flow
1
1
Difficult to Open or Remove Packaging Material
1
1
Electromagnetic Compatibility Problem
1
1
Gas/Air Leak
1
1
Obstruction of Flow
1
1
Failure to Calibrate
1
1
High Test Results
1
1
Low Test Results
1
1
Low Readings
1
1
Material Perforation
1
1
Microbial Contamination of Device
1
1
Device Contamination with Body Fluid
1
1
Device Displays Incorrect Message
1
1
Battery Problem
1
1
Moisture Damage
1
1
No Device Output
1
1
Material Rupture
1
1
Device Difficult to Setup or Prepare
1
1
Failure to Reset
1
1
False Positive Result
1
1
Thermal Decomposition of Device
1
1
Complete Blockage
1
1
Device Alarm System
1
1
Difficult to Flush
1
1
Material Fragmentation
1
1
Material Frayed
1
1
Excess Flow or Over-Infusion
1
1
Output below Specifications
1
1
Pressure Problem
1
1
Scratched Material
1
1
Unintended Movement
1
1
Data Problem
1
1
Incomplete or Inadequate Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
415
415
No Consequences Or Impact To Patient
223
223
No Known Impact Or Consequence To Patient
129
129
Insufficient Information
20
20
No Patient Involvement
18
18
Vascular Dissection
18
18
Hemorrhage/Bleeding
16
16
Device Embedded In Tissue or Plaque
15
15
Cerebrospinal Fluid Leakage
11
11
Foreign Body In Patient
10
10
No Code Available
9
9
Air Embolism
9
9
Blood Loss
8
8
Loss of consciousness
7
7
Burn(s)
6
6
Low Blood Pressure/ Hypotension
6
6
Pericardial Effusion
5
5
Unspecified Infection
4
4
High Blood Pressure/ Hypertension
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Thrombosis/Thrombus
2
2
Bradycardia
2
2
Obstruction/Occlusion
2
2
Perforation
2
2
Vasoconstriction
2
2
Death
2
2
Cardiac Arrest
2
2
Chest Pain
1
1
Cyanosis
1
1
Atrial Fibrillation
1
1
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Hematoma
1
1
Hepatitis
1
1
Ischemia
1
1
Memory Loss/Impairment
1
1
Muscle Weakness
1
1
Overdose
1
1
Paralysis
1
1
Ventricular Fibrillation
1
1
Perforation of Vessels
1
1
Dizziness
1
1
Electrolyte Imbalance
1
1
ST Segment Elevation
1
1
Thrombosis
1
1
Tissue Damage
1
1
Transient Ischemic Attack
1
1
Low Oxygen Saturation
1
1
Burn, Thermal
1
1
Cognitive Changes
1
1
Cardiac Tamponade
1
1
Superficial (First Degree) Burn
1
1
Ischemia Stroke
1
1
Tics/Tremor
1
1
Embolism/Embolus
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
II
Jun-25-2021
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