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TPLC
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show TPLC since
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Device
transducer, pressure, catheter tip
Product Code
DXO
Regulation Number
870.2870
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
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
164
164
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
169
169
Detachment of Device or Device Component
167
167
Communication or Transmission Problem
89
89
Material Separation
71
71
Incorrect Measurement
60
60
Contamination
55
55
Break
44
44
Failure to Advance
43
43
Difficult to Remove
40
40
Device Contamination with Chemical or Other Material
38
38
Adverse Event Without Identified Device or Use Problem
37
37
Fluid/Blood Leak
29
29
Fracture
29
29
Failure to Zero
24
24
Improper or Incorrect Procedure or Method
22
22
Leak/Splash
22
22
Difficult to Advance
21
21
Material Deformation
20
20
Contamination /Decontamination Problem
19
19
Deformation Due to Compressive Stress
17
17
Material Integrity Problem
15
15
Use of Device Problem
14
14
Disconnection
12
12
Material Split, Cut or Torn
11
11
Physical Resistance/Sticking
10
10
Output Problem
10
10
Entrapment of Device
10
10
Inaccurate Flow Rate
9
9
Stretched
8
8
Peeled/Delaminated
7
7
Device Contaminated During Manufacture or Shipping
7
7
Mechanical Problem
6
6
Loose or Intermittent Connection
6
6
Unsealed Device Packaging
6
6
Defective Device
6
6
Material Twisted/Bent
5
5
Calibration Problem
5
5
Air/Gas in Device
5
5
Pacing Problem
5
5
Failure to Clean Adequately
4
4
Positioning Problem
4
4
Mechanical Jam
4
4
Appropriate Term/Code Not Available
3
3
Flushing Problem
3
3
Inaccurate Information
3
3
Contamination of Device Ingredient or Reagent
3
3
Tear, Rip or Hole in Device Packaging
3
3
Defective Component
3
3
Insufficient Information
3
3
Material Frayed
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
494
494
No Consequences Or Impact To Patient
223
223
No Known Impact Or Consequence To Patient
129
129
Hemorrhage/Bleeding
25
25
Insufficient Information
21
21
Vascular Dissection
20
20
No Patient Involvement
18
18
Device Embedded In Tissue or Plaque
16
16
Foreign Body In Patient
14
14
Cerebrospinal Fluid Leakage
13
13
Air Embolism
9
9
No Code Available
9
9
Blood Loss
8
8
Low Blood Pressure/ Hypotension
7
7
Loss of consciousness
7
7
Pericardial Effusion
6
6
Burn(s)
6
6
Unspecified Infection
4
4
High Blood Pressure/ Hypertension
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Death
2
2
Bradycardia
2
2
Thrombosis/Thrombus
2
2
Perforation
2
2
Vasoconstriction
2
2
Transient Ischemic Attack
2
2
Cardiac Arrest
2
2
Obstruction/Occlusion
2
2
Atrial Fibrillation
2
2
Cognitive Changes
1
1
Overdose
1
1
Electrolyte Imbalance
1
1
Cardiac Tamponade
1
1
Burn, Thermal
1
1
Hematoma
1
1
Hepatitis
1
1
Paralysis
1
1
Ventricular Fibrillation
1
1
Dizziness
1
1
Memory Loss/Impairment
1
1
Exposure to Body Fluids
1
1
Chest Pain
1
1
Thrombosis
1
1
Pain
1
1
Perforation of Vessels
1
1
Embolism/Embolus
1
1
Aneurysm
1
1
Tissue Damage
1
1
Superficial (First Degree) Burn
1
1
Cyanosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Edwards Lifesciences, LLC
II
Jun-25-2021
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