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TPLC
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show TPLC since
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Device
catheter, steerable
Product Code
DRA
Regulation Number
870.1280
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
1
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ACUTUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
FREUDENBERG MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC CRYOCATH LP
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
700
700
2020
703
703
2021
741
778
2022
652
654
2023
787
787
2024
1247
1247
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1970
2009
Leak/Splash
1059
1059
Air/Gas in Device
438
438
Gas/Air Leak
327
327
Material Twisted/Bent
299
299
Material Integrity Problem
161
161
Deformation Due to Compressive Stress
132
132
Break
100
100
Failure to Advance
90
90
Device Contamination with Body Fluid
83
83
Material Split, Cut or Torn
82
82
Fluid/Blood Leak
81
81
Positioning Failure
81
81
Unintended Movement
76
76
Difficult to Insert
75
75
Compatibility Problem
67
67
Improper or Incorrect Procedure or Method
63
63
Difficult to Remove
61
61
Material Deformation
56
56
Difficult or Delayed Positioning
51
51
Difficult to Advance
50
50
Crack
35
35
Use of Device Problem
33
33
Off-Label Use
30
30
Noise, Audible
28
28
Material Separation
27
27
Unstable
25
25
Peeled/Delaminated
25
25
Device Handling Problem
22
22
Difficult to Flush
22
22
Physical Resistance/Sticking
22
22
Product Quality Problem
21
21
Device Contamination with Chemical or Other Material
21
21
Suction Problem
18
18
Mechanical Problem
15
15
Device-Device Incompatibility
14
14
Entrapment of Device
14
14
Detachment of Device or Device Component
13
13
Tear, Rip or Hole in Device Packaging
11
11
Appropriate Term/Code Not Available
9
9
Signal Artifact/Noise
8
8
Positioning Problem
8
8
Mechanical Jam
7
7
Insufficient Information
7
7
Activation, Positioning or Separation Problem
6
6
Device Markings/Labelling Problem
6
6
Device Damaged by Another Device
5
5
Packaging Problem
5
5
No Apparent Adverse Event
5
5
Loose or Intermittent Connection
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1926
1926
Pericardial Effusion
440
440
Low Blood Pressure/ Hypotension
385
385
Perforation
345
384
Cardiac Tamponade
302
302
No Consequences Or Impact To Patient
261
261
No Known Impact Or Consequence To Patient
236
236
Atrial Perforation
215
215
Air Embolism
181
181
Thrombosis/Thrombus
178
178
Hemorrhage/Bleeding
177
177
No Patient Involvement
150
150
Hematoma
144
144
Non specific EKG/ECG Changes
122
122
Cardiac Perforation
117
117
Thrombosis
84
84
Pseudoaneurysm
82
82
Fistula
77
77
Cardiac Arrest
69
69
Stroke/CVA
68
68
Hypoxia
60
60
Unspecified Tissue Injury
53
53
Arrhythmia
45
45
Perforation of Vessels
38
38
Tachycardia
38
38
Insufficient Information
38
38
Cardiovascular Insufficiency
34
34
Death
34
34
ST Segment Elevation
28
28
Bradycardia
27
27
Embolism/Embolus
27
27
Embolism
26
26
Vascular System (Circulation), Impaired
26
26
Chest Pain
26
26
Pain
24
24
Tissue Damage
22
22
Dyspnea
22
22
Heart Failure/Congestive Heart Failure
20
20
Transient Ischemic Attack
19
19
Vascular Dissection
18
18
Inflammation
18
18
High Blood Pressure/ Hypertension
18
18
Myocardial Infarction
17
17
No Code Available
17
17
Atrial Flutter
17
17
Heart Failure
17
17
Ventricular Fibrillation
15
15
Heart Block
15
15
Respiratory Distress
14
14
Paralysis
13
13
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
I
Mar-26-2024
2
Medtronic Perfusion Systems
II
Sep-22-2021
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