Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
catheter, intracardiac mapping, high-density array
Product Code
MTD
Regulation Number
870.1220
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
ST. JUDE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
STERILMED INC. (JOHNSON AND JOHNSON)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
49
49
2019
77
77
2020
87
87
2021
99
99
2022
145
145
2023
149
149
Device Problems
MDRs with this Device Problem
Events in those MDRs
Patient Device Interaction Problem
170
170
Adverse Event Without Identified Device or Use Problem
98
98
Entrapment of Device
81
81
Detachment of Device or Device Component
62
62
Device Contamination with Body Fluid
52
52
Contamination /Decontamination Problem
42
42
Signal Artifact/Noise
34
34
Coagulation in Device or Device Ingredient
31
31
Material Protrusion/Extrusion
31
31
Material Twisted/Bent
30
30
Sharp Edges
30
30
Device-Device Incompatibility
29
29
Break
20
20
Material Deformation
18
18
Complete Blockage
16
16
Material Separation
16
16
Display or Visual Feedback Problem
14
14
Mechanical Jam
9
9
Positioning Problem
7
7
Tear, Rip or Hole in Device Packaging
7
7
Communication or Transmission Problem
5
5
Delivered as Unsterile Product
5
5
Separation Problem
5
5
Material Split, Cut or Torn
4
4
Appropriate Term/Code Not Available
4
4
Material Frayed
4
4
Partial Blockage
3
3
Device Displays Incorrect Message
3
3
Application Program Problem
3
3
Device Issue
3
3
Use of Device Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Device Contamination with Chemical or Other Material
3
3
Device Sensing Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Packaging Problem
2
2
Difficult to Remove
2
2
Material Too Rigid or Stiff
2
2
Physical Resistance
2
2
Contamination
2
2
No Display/Image
2
2
Bent
2
2
Hole In Material
2
2
Off-Label Use
2
2
Fluid/Blood Leak
2
2
Fracture
2
2
Material Fragmentation
2
2
Material Puncture/Hole
1
1
Inability to Irrigate
1
1
Defective Device
1
1
Obstruction of Flow
1
1
Failure to Advance
1
1
Failure to Sense
1
1
Stretched
1
1
Failure to Unfold or Unwrap
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Output Problem
1
1
No Flow
1
1
Electrical Shorting
1
1
Electromagnetic Compatibility Problem
1
1
Gas/Air Leak
1
1
Material Integrity Problem
1
1
Protective Measures Problem
1
1
Scratched Material
1
1
Physical Resistance/Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
229
229
No Consequences Or Impact To Patient
95
95
Cardiac Tamponade
93
93
Foreign Body In Patient
49
49
No Code Available
38
38
Cardiac Perforation
24
24
Cardiac Arrest
18
18
Stroke/CVA
13
13
Air Embolism
12
12
Ischemic Heart Disease
9
9
Thrombosis/Thrombus
8
8
No Known Impact Or Consequence To Patient
7
7
Rupture
7
7
Transient Ischemic Attack
7
7
Device Embedded In Tissue or Plaque
5
5
Pericardial Effusion
5
5
Insufficient Information
5
5
Unspecified Tissue Injury
4
4
Ventricular Fibrillation
4
4
Hematoma
4
4
Low Blood Pressure/ Hypotension
4
4
Paralysis
3
3
Tachycardia
3
3
Death
3
3
Arrhythmia
3
3
Pseudoaneurysm
3
3
Heart Block
3
3
Vascular Dissection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Complete Heart Block
2
2
Cardiogenic Shock
2
2
Ventricular Tachycardia
2
2
Perforation of Vessels
2
2
Urinary Tract Infection
2
2
Vasoconstriction
2
2
Bradycardia
2
2
Hemorrhage/Bleeding
2
2
Thrombosis
2
2
Myocardial Infarction
2
2
Nerve Damage
1
1
Mitral Insufficiency
1
1
Mitral Regurgitation
1
1
Thrombus
1
1
Pleural Effusion
1
1
Pneumothorax
1
1
Anemia
1
1
Aortic Insufficiency
1
1
Visual Impairment
1
1
Pulmonary Embolism
1
1
Thromboembolism
1
1
No Information
1
1
Heart Failure/Congestive Heart Failure
1
1
Pericarditis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Jun-01-2022
2
BIOSENSE WEBSTER
II
Jun-16-2020
-
-