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TPLC
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Device
catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Definition
For the treatment of atrial fibrillation.
Product Code
OAE
Device Class
3
Premarket Approvals (PMA)
2019
2020
2021
2022
2023
2024
34
27
31
26
43
22
MDR Year
MDR Reports
MDR Events
2019
908
908
2020
744
744
2021
914
914
2022
1162
1162
2023
1312
1312
2024
1383
1383
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2601
2601
Material Twisted/Bent
721
721
Material Integrity Problem
491
491
Patient Device Interaction Problem
400
400
Optical Problem
371
371
Device Contamination with Body Fluid
354
354
Communication or Transmission Problem
235
235
Fluid/Blood Leak
234
234
Protective Measures Problem
204
204
Fracture
186
186
Incorrect, Inadequate or Imprecise Result or Readings
118
118
Electrical Shorting
117
117
Gas/Air Leak
101
101
Material Deformation
98
98
Temperature Problem
90
90
Coagulation in Device or Device Ingredient
81
81
Improper Flow or Infusion
75
75
Insufficient Cooling
72
72
Signal Artifact/Noise
68
68
Break
67
67
Mechanical Problem
62
62
Obstruction of Flow
61
61
Contamination /Decontamination Problem
60
60
Use of Device Problem
60
60
Leak/Splash
53
53
Display or Visual Feedback Problem
46
46
No Apparent Adverse Event
46
46
High impedance
44
44
Compatibility Problem
43
43
Overheating of Device
34
34
Impedance Problem
31
31
Failure to Sense
31
31
Infusion or Flow Problem
30
30
Appropriate Term/Code Not Available
26
26
Increase in Pressure
24
24
Device Contamination with Chemical or Other Material
20
20
Insufficient Information
19
19
Device Displays Incorrect Message
19
19
Off-Label Use
19
19
Output Problem
16
16
Device Handling Problem
15
15
Failure to Pump
15
15
Defective Device
14
14
Entrapment of Device
14
14
Excessive Cooling
13
13
Device Sensing Problem
12
12
Intermittent Communication Failure
12
12
Improper or Incorrect Procedure or Method
12
12
Material Frayed
12
12
Material Puncture/Hole
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2603
2603
Cardiac Perforation
938
938
Nerve Damage
574
574
No Consequences Or Impact To Patient
396
396
Cardiac Tamponade
386
386
No Known Impact Or Consequence To Patient
380
380
Pericardial Effusion
312
312
Low Blood Pressure/ Hypotension
213
213
Stroke/CVA
210
210
Heart Block
87
87
Arrhythmia
77
77
Thrombosis/Thrombus
69
69
Pericarditis
67
67
Hemorrhage/Bleeding
61
61
Chest Pain
61
61
Fistula
58
58
Cardiac Arrest
54
54
Transient Ischemic Attack
51
51
Tachycardia
48
48
Non specific EKG/ECG Changes
45
45
Death
44
44
Insufficient Information
43
43
Stenosis
42
42
Dyspnea
40
40
Inflammation
39
39
Patient Problem/Medical Problem
38
38
Perforation of Esophagus
38
38
Atrial Fibrillation
37
37
Pseudoaneurysm
36
36
Atrial Flutter
35
35
Hematoma
33
33
Thrombus
31
31
Air Embolism
30
30
Paresis
28
28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
27
27
Heart Failure/Congestive Heart Failure
26
26
Hemoptysis
26
26
Pulmonary Valve Stenosis
25
25
Embolism/Embolus
24
24
Perforation
24
24
Vascular Dissection
24
24
ST Segment Elevation
23
23
Pain
22
22
Embolism
21
21
Paralysis
19
19
Ventricular Fibrillation
18
18
Pleural Effusion
18
18
Tissue Damage
17
17
Vomiting
17
17
Bradycardia
17
17
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Jul-07-2022
2
Abbott
II
Apr-19-2022
3
Abbott
II
Jul-10-2020
4
Abbott Laboratories Inc. (St Jude Medical)
II
Apr-09-2020
5
EPIX THERAPEUTICS, INC
II
Mar-29-2021
6
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
III
Mar-28-2019
7
St. Jude Medical, Atrial Fibrillation Division, Inc.
II
Jan-25-2024
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