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TPLC
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Device
catheter, steerable
Regulation Description
Steerable catheter.
Product Code
DRA
Regulation Number
870.1280
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
ACUTUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
KARDIUM INC.
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC CRYOCATH LP
SUBSTANTIALLY EQUIVALENT
1
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
703
703
2021
741
778
2022
652
654
2023
788
788
2024
1966
1966
2025
2142
2142
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2275
2314
Air/Gas in Device
1615
1615
Leak/Splash
1502
1502
Material Twisted/Bent
442
442
Material Integrity Problem
355
355
Gas/Air Leak
349
349
Device Contamination with Body Fluid
224
224
Deformation Due to Compressive Stress
141
141
Break
116
116
Difficult to Advance
110
110
Failure to Advance
98
98
Compatibility Problem
88
88
Unintended Movement
88
88
Positioning Failure
85
85
Difficult to Insert
82
82
Material Split, Cut or Torn
76
76
Difficult to Remove
75
75
Suction Problem
71
71
Difficult to Flush
66
66
Material Deformation
62
62
Use of Device Problem
60
60
Improper or Incorrect Procedure or Method
57
57
Fluid/Blood Leak
56
56
Crack
56
56
Difficult or Delayed Positioning
49
49
Device-Device Incompatibility
45
45
Device Contamination with Chemical or Other Material
38
38
Off-Label Use
37
37
Device Handling Problem
34
34
Physical Resistance/Sticking
32
32
Peeled/Delaminated
31
31
Noise, Audible
30
30
Detachment of Device or Device Component
28
28
Unstable
27
27
Product Quality Problem
26
26
Material Separation
25
25
Mechanical Problem
25
25
Positioning Problem
19
19
Entrapment of Device
16
16
Improper Flow or Infusion
13
13
Material Perforation
11
11
Tear, Rip or Hole in Device Packaging
11
11
Packaging Problem
10
10
Signal Artifact/Noise
9
9
Flushing Problem
8
8
Insufficient Information
8
8
Mechanical Jam
8
8
Appropriate Term/Code Not Available
7
7
Loose or Intermittent Connection
7
7
Unsealed Device Packaging
7
7
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4140
4140
Pericardial Effusion
485
485
Low Blood Pressure/ Hypotension
476
476
Perforation
414
453
Cardiac Tamponade
341
341
Thrombosis/Thrombus
254
254
Air Embolism
245
245
Non specific EKG/ECG Changes
205
205
Hemorrhage/Bleeding
189
189
No Consequences Or Impact To Patient
180
180
Hematoma
133
133
Atrial Perforation
133
133
Cardiac Perforation
127
127
Cardiac Arrest
95
95
Stroke/CVA
90
90
Pseudoaneurysm
81
81
No Patient Involvement
80
80
No Known Impact Or Consequence To Patient
79
79
Fistula
71
71
Hypoxia
69
69
Unspecified Tissue Injury
65
65
Perforation of Vessels
58
58
Tachycardia
51
51
Thrombosis
49
49
Arrhythmia
47
47
Insufficient Information
44
44
Bradycardia
36
36
Cardiovascular Insufficiency
36
36
Embolism/Embolus
34
34
Vascular Dissection
27
27
Heart Failure/Congestive Heart Failure
27
27
Pain
25
25
Ventricular Fibrillation
24
24
Chest Pain
24
24
Dyspnea
24
24
Myocardial Infarction
22
22
Transient Ischemic Attack
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Atrial Flutter
20
20
Atrial Fibrillation
19
19
Heart Block
19
19
High Blood Pressure/ Hypertension
18
18
ST Segment Elevation
18
18
Death
17
17
Embolism
16
16
Inflammation
16
16
Paralysis
14
14
Cardiogenic Shock
13
13
Heart Failure
12
12
Respiratory Distress
12
12
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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