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TPLC
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Device
catheter, electrode recording, or probe, electrode recording
Product Code
DRF
Regulation Number
870.1220
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ACCESS POINT TECHNOLOGIES EP, INC.
SUBSTANTIALLY EQUIVALENT
1
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
2
BIOSENSE WEBSTER, INC.
SUBSTANTIALLY EQUIVALENT
2
BIOTRONICK, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOTRONIK, INC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
6
CATHRXLTD
SUBSTANTIALLY EQUIVALENT
1
1. K211327
Khelix Steerable Electrophysiology Catheters, Khel
...
INNOVATIVE HEALTH, LLC.
SUBSTANTIALLY EQUIVALENT
6
MEDFACT ENGINEERING GMBH
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC
SUBSTANTIALLY EQUIVALENT
2
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC, INC.
SUBSTANTIALLY EQUIVALENT
2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ST. JUDE MEDICAL
SUBSTANTIALLY EQUIVALENT
1
SYNAPTIC MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
Premarket Approvals (PMA)
2016
2017
2018
2019
2020
2021
2022
2023
2024
2
6
1
1
3
7
3
1
0
MDR Year
MDR Reports
MDR Events
2016
383
383
2017
458
458
2018
723
723
2019
669
669
2020
651
651
2021
625
625
2022
613
613
2023
686
686
2024
159
159
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2085
2085
Material Twisted/Bent
577
577
Material Deformation
317
317
Patient Device Interaction Problem
265
265
Entrapment of Device
199
199
Material Integrity Problem
166
166
Difficult to Remove
114
114
Appropriate Term/Code Not Available
111
111
Fracture
90
90
Signal Artifact/Noise
86
86
Insufficient Information
82
82
Break
75
75
Material Separation
74
74
Kinked
69
69
Detachment of Device or Device Component
67
67
Communication or Transmission Problem
50
50
Material Frayed
49
49
Fluid/Blood Leak
45
45
Device Operates Differently Than Expected
44
44
Mechanical Problem
42
42
Device Contamination with Chemical or Other Material
39
39
Compatibility Problem
39
39
Mechanical Jam
38
38
Contamination /Decontamination Problem
37
37
Activation, Positioning or Separation Problem
34
34
Positioning Problem
33
33
Material Protrusion/Extrusion
30
30
Device Sensing Problem
28
28
Defective Device
28
28
Display or Visual Feedback Problem
26
26
Detachment Of Device Component
24
24
Leak/Splash
23
23
Failure to Sense
23
23
Material Perforation
22
22
Device-Device Incompatibility
22
22
Improper Flow or Infusion
22
22
Device Displays Incorrect Message
22
22
Difficult to Insert
22
22
Delivered as Unsterile Product
20
20
Material Split, Cut or Torn
20
20
Tear, Rip or Hole in Device Packaging
18
18
Use of Device Problem
15
15
Contamination
15
15
Failure to Capture
15
15
Coagulation in Device or Device Ingredient
15
15
Noise, Audible
15
15
Material Puncture/Hole
14
14
Sticking
13
13
Device Contamination with Body Fluid
12
12
Improper or Incorrect Procedure or Method
11
11
Poor Quality Image
11
11
Device Dislodged or Dislocated
11
11
Knotted
11
11
Output Problem
11
11
Component Misassembled
11
11
Packaging Problem
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Obstruction of Flow
10
10
Failure to Unfold or Unwrap
8
8
Connection Problem
8
8
Electrical /Electronic Property Problem
8
8
Bent
8
8
Device Handling Problem
8
8
Sharp Edges
8
8
No Apparent Adverse Event
7
7
Data Problem
7
7
No Display/Image
7
7
Hole In Material
7
7
Device Issue
7
7
Expiration Date Error
6
6
Defective Component
6
6
Electrical Shorting
6
6
Difficult to Advance
6
6
High impedance
6
6
Pacing Problem
6
6
Insufficient Cooling
6
6
Temperature Problem
6
6
Protective Measures Problem
5
5
Mechanics Altered
5
5
Separation Problem
5
5
Physical Resistance/Sticking
5
5
Air Leak
5
5
Device Alarm System
5
5
Unsealed Device Packaging
5
5
Material Rupture
5
5
Device Damaged by Another Device
5
5
Device Packaging Compromised
5
5
Physical Resistance
5
5
Failure to Advance
5
5
High Readings
4
4
Structural Problem
4
4
Device Damaged Prior to Use
4
4
Device Inoperable
4
4
Difficult to Open or Remove Packaging Material
4
4
Device Operational Issue
4
4
Malposition of Device
4
4
Unable to Obtain Readings
4
4
Crack
4
4
Air/Gas in Device
4
4
Scratched Material
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1135
1135
Cardiac Tamponade
719
719
Cardiac Perforation
700
700
No Consequences Or Impact To Patient
661
661
Pericardial Effusion
553
553
No Known Impact Or Consequence To Patient
430
430
Low Blood Pressure/ Hypotension
345
345
Stroke/CVA
151
151
Death
113
113
Hematoma
96
98
Fistula
90
92
No Code Available
84
84
Cardiac Arrest
69
69
Pseudoaneurysm
64
64
Hemorrhage/Bleeding
62
62
Chest Pain
55
55
Heart Block
55
55
Arrhythmia
53
53
Vascular Dissection
52
52
No Patient Involvement
48
48
Transient Ischemic Attack
39
39
Tachycardia
38
38
Insufficient Information
38
38
Air Embolism
36
36
Perforation
34
34
Thrombosis/Thrombus
32
32
Tissue Damage
30
30
Hemoptysis
30
30
Paralysis
26
26
ST Segment Elevation
24
24
Dyspnea
23
23
Complete Heart Block
23
23
Foreign Body In Patient
21
21
Non specific EKG/ECG Changes
21
21
Bradycardia
20
20
Inflammation
20
20
Nerve Damage
19
19
Atrial Fibrillation
19
19
Blood Loss
19
19
Unspecified Tissue Injury
19
19
Thrombus
18
18
Vascular System (Circulation), Impaired
17
17
Ischemia Stroke
16
16
Thrombosis
15
15
Perforation of Vessels
15
15
Rupture
15
15
Embolism
15
15
Fever
15
15
Physical Entrapment
14
14
Embolism/Embolus
14
14
Pericarditis
13
13
Vaso-Vagal Response
13
13
Great Vessel Perforation
13
13
Ventricular Fibrillation
13
13
Ventricular Tachycardia
13
13
Sepsis
13
13
Myocardial Infarction
13
13
Pleural Effusion
12
12
Pneumothorax
12
12
Heart Failure
12
12
Device Embedded In Tissue or Plaque
12
12
Partial thickness (Second Degree) Burn
11
11
Pneumonia
11
11
Cardiopulmonary Arrest
11
11
No Information
10
10
Mitral Valve Insufficiency/ Regurgitation
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Heart Failure/Congestive Heart Failure
10
10
Atrial Flutter
9
9
Pain
9
9
Vasoconstriction
9
9
Cardiogenic Shock
9
9
Stenosis
8
8
Injury
8
8
Pulmonary Edema
8
8
Respiratory Failure
8
8
Diminished Pulse Pressure
7
7
Pulmonary Valve Stenosis
7
7
Paresis
7
7
Loss of consciousness
7
7
Dizziness
7
7
Pulmonary Embolism
7
7
Unspecified Infection
7
7
Nausea
6
6
High Blood Pressure/ Hypertension
6
6
Intracranial Hemorrhage
6
6
Hemothorax
6
6
Laceration(s) of Esophagus
6
6
Not Applicable
6
6
Thromboembolism
5
5
Aortic Dissection
5
5
Retroperitoneal Hemorrhage
5
5
Weakness
5
5
Discomfort
5
5
Complaint, Ill-Defined
5
5
Muscle Weakness
5
5
Neurological Deficit/Dysfunction
5
5
Hypoxia
5
5
Cardiomyopathy
5
5
Infarction, Cerebral
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Arrow International Inc
II
Sep-19-2018
2
Irvine Biomedical Inc, a St. Jude Medical Co.
II
Sep-24-2020
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