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TPLC
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Device
catheter, intracardiac mapping, high-density array
Regulation Description
Electrode recording catheter or electrode recording probe.
Product Code
MTD
Regulation Number
870.1220
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ABLACON, INC.
SUBSTANTIALLY EQUIVALENT
1
ACUTUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
BIOSENSE WEBSTER INC.
SUBSTANTIALLY EQUIVALENT
1
BIOSENSE WEBSTER, INC
SUBSTANTIALLY EQUIVALENT
1
BIOSENSE WEBSTER, INC.
SUBSTANTIALLY EQUIVALENT
3
INNOVATIVE HEALTH, LLC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
1
STERILMED INC. (JOHNSON AND JOHNSON)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
87
87
2021
99
99
2022
145
145
2023
184
184
2024
379
379
2025
65
65
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient Device Interaction Problem
262
262
Obstruction of Flow
187
187
Entrapment of Device
80
80
Device Contamination with Body Fluid
80
80
Detachment of Device or Device Component
69
69
Contamination /Decontamination Problem
64
64
Signal Artifact/Noise
63
63
Adverse Event Without Identified Device or Use Problem
61
61
Material Twisted/Bent
55
55
Device-Device Incompatibility
45
45
Material Protrusion/Extrusion
39
39
Coagulation in Device or Device Ingredient
39
39
Break
29
29
Display or Visual Feedback Problem
25
25
Material Separation
19
19
Complete Blockage
18
18
Sharp Edges
18
18
Material Deformation
16
16
Tear, Rip or Hole in Device Packaging
15
15
Mechanical Jam
15
15
Communication or Transmission Problem
14
14
Manufacturing, Packaging or Shipping Problem
13
13
Positioning Problem
12
12
Improper or Incorrect Procedure or Method
9
9
Packaging Problem
8
8
Off-Label Use
7
7
Delivered as Unsterile Product
6
6
Failure to Sense
5
5
Appropriate Term/Code Not Available
5
5
Application Program Problem
5
5
Electrical Shorting
4
4
Separation Problem
4
4
Failure to Advance
4
4
Contamination
3
3
Therapeutic or Diagnostic Output Failure
3
3
Partial Blockage
3
3
Material Too Rigid or Stiff
2
2
Material Integrity Problem
2
2
Insufficient Information
2
2
Device Sensing Problem
2
2
Fluid/Blood Leak
1
1
Protective Measures Problem
1
1
Failure to Unfold or Unwrap
1
1
Device Emits Odor
1
1
Electromagnetic Compatibility Problem
1
1
Component Missing
1
1
Use of Device Problem
1
1
Device Alarm System
1
1
Physical Resistance/Sticking
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
606
606
Cardiac Tamponade
124
124
Foreign Body In Patient
61
61
No Consequences Or Impact To Patient
35
35
Cardiac Arrest
24
24
Cardiac Perforation
17
17
Stroke/CVA
16
16
Ischemic Heart Disease
15
15
Air Embolism
14
14
No Code Available
12
12
Thrombosis/Thrombus
11
11
Low Blood Pressure/ Hypotension
9
9
Pericardial Effusion
9
9
Heart Block
8
8
Unspecified Tissue Injury
6
6
Insufficient Information
6
6
Ventricular Fibrillation
6
6
Transient Ischemic Attack
5
5
Rupture
5
5
No Known Impact Or Consequence To Patient
4
4
Tachycardia
4
4
Perforation of Vessels
4
4
Hematoma
3
3
Pseudoaneurysm
3
3
Death
3
3
Arrhythmia
3
3
Pericarditis
2
2
Paralysis
2
2
Vasoconstriction
2
2
Ventricular Tachycardia
2
2
Thrombosis
2
2
Cardiogenic Shock
2
2
Bradycardia
2
2
Pneumothorax
2
2
Myocardial Infarction
2
2
Hemorrhage/Bleeding
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Respiratory Failure
2
2
Urinary Tract Infection
2
2
Cognitive Changes
1
1
Anemia
1
1
Unspecified Nervous System Problem
1
1
Perforation
1
1
Respiratory Arrest
1
1
Nerve Damage
1
1
Pleural Effusion
1
1
Mitral Valve Insufficiency/ Regurgitation
1
1
Visual Impairment
1
1
Asystole
1
1
Heart Failure/Congestive Heart Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Jun-01-2022
2
BIOSENSE WEBSTER
II
Jun-16-2020
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