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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
ABBOTT VASCULAR
SUBSTANTIALLY EQUIVALENT
3
ACUTUS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
2
CARDIOFOCUS, INC.
SUBSTANTIALLY EQUIVALENT
1
CARDIOSOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
EVALVE INC
SUBSTANTIALLY EQUIVALENT
4
FREUDENBERG MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
GREATBATCH MEDICAL
SUBSTANTIALLY EQUIVALENT
1
HANSEN MEDICAL
SUBSTANTIALLY EQUIVALENT
2
HANSEN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
MEDTRONIC CRYOCATH LP
SUBSTANTIALLY EQUIVALENT
4
MEDTRONIC INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
212
212
2015
350
350
2016
481
481
2017
625
625
2018
633
633
2019
700
700
2020
703
703
2021
741
778
2022
652
654
2023
787
787
2024
576
576
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
2444
2483
Leak/Splash
1217
1217
Gas/Air Leak
337
337
Air Leak
330
330
Material Twisted/Bent
309
309
Fluid/Blood Leak
212
212
Appropriate Term/Code Not Available
207
207
Break
196
196
Air/Gas in Device
194
194
Material Integrity Problem
137
137
Insufficient Information
120
120
Deformation Due to Compressive Stress
119
119
Failure to Advance
113
113
Torn Material
107
107
Difficult to Insert
102
102
Difficult to Remove
101
101
Mechanical Problem
97
97
Improper or Incorrect Procedure or Method
96
96
Device Operates Differently Than Expected
92
92
Material Split, Cut or Torn
81
81
Unintended Movement
79
79
Kinked
76
76
Positioning Failure
75
75
Material Deformation
68
68
Compatibility Problem
61
61
Difficult or Delayed Positioning
58
58
Detachment Of Device Component
50
50
Unstable
49
49
Device Contamination with Body Fluid
49
49
Difficult to Advance
42
42
Crack
39
39
Loose or Intermittent Connection
31
31
Noise, Audible
29
29
Material Separation
28
28
Physical Resistance
27
27
Device Contamination with Chemical or Other Material
27
27
Peeled/Delaminated
26
26
Use of Device Problem
25
25
Off-Label Use
23
23
Device Handling Problem
21
21
Physical Resistance/Sticking
21
21
Product Quality Problem
19
19
Difficult To Position
19
19
Difficult to Flush
18
18
Entrapment of Device
15
15
Detachment of Device or Device Component
13
13
Loss of or Failure to Bond
12
12
Device Damaged by Another Device
10
10
Device Slipped
10
10
Tear, Rip or Hole in Device Packaging
9
9
Aspiration Issue
9
9
Activation, Positioning or Separation Problem
8
8
Device-Device Incompatibility
8
8
Signal Artifact/Noise
8
8
Delivered as Unsterile Product
8
8
No Apparent Adverse Event
8
8
Physical Property Issue
8
8
Positioning Problem
7
7
Mechanical Jam
7
7
Bent
7
7
Suction Problem
6
6
Device Markings/Labelling Problem
6
6
Disconnection
4
4
Device Expiration Issue
3
3
Device Displays Incorrect Message
3
3
Human-Device Interface Problem
3
3
Device Dislodged or Dislocated
3
3
Mechanics Altered
3
3
Device Contaminated During Manufacture or Shipping
3
3
Packaging Problem
3
3
Temperature Problem
2
2
Difficult to Open or Close
2
2
Improper Flow or Infusion
2
2
Material Rupture
2
2
Defective Device
2
2
Material Perforation
2
2
Unsealed Device Packaging
2
2
Material Frayed
2
2
Inflation Problem
1
1
Flushing Problem
1
1
Display or Visual Feedback Problem
1
1
Problem with Removal of Enzymatic Cleaner
1
1
Contamination
1
1
Application Interface Becomes Non-Functional Or Program Exits Abnormally
1
1
Deflation Problem
1
1
Device Appears to Trigger Rejection
1
1
Loss of Power
1
1
Device Difficult to Setup or Prepare
1
1
Occlusion Within Device
1
1
Migration or Expulsion of Device
1
1
Nonstandard Device
1
1
Defective Component
1
1
Out-Of-Box Failure
1
1
Obstruction of Flow
1
1
Incorrect Or Inadequate Test Results
1
1
Structural Problem
1
1
Sticking
1
1
Defibrillation/Stimulation Problem
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1434
1434
No Known Impact Or Consequence To Patient
769
769
No Consequences Or Impact To Patient
649
649
Pericardial Effusion
610
610
Low Blood Pressure/ Hypotension
530
530
Cardiac Tamponade
449
449
Atrial Perforation
364
364
No Patient Involvement
362
362
Perforation
347
386
Air Embolism
250
250
Hemorrhage/Bleeding
246
246
Hematoma
232
233
Thrombosis
174
174
Thrombosis/Thrombus
161
161
Pseudoaneurysm
160
160
Cardiac Perforation
154
154
ST Segment Elevation
137
137
Fistula
118
119
Non specific EKG/ECG Changes
110
110
Cardiac Arrest
102
103
Death
78
78
Stroke/CVA
71
71
Hypoxia
53
53
Arrhythmia
49
49
Unspecified Tissue Injury
48
48
Bradycardia
46
46
Tissue Damage
45
45
Vascular System (Circulation), Impaired
44
44
No Code Available
44
44
Embolism
43
43
Chest Pain
42
42
Pain
41
41
Blood Loss
39
40
Perforation of Vessels
37
37
Tachycardia
35
35
Insufficient Information
34
34
Dyspnea
30
30
Cardiovascular Insufficiency
29
29
Ventricular Fibrillation
25
25
Heart Failure
23
23
High Blood Pressure/ Hypertension
23
23
Embolism/Embolus
22
22
Heart Failure/Congestive Heart Failure
20
20
Vascular Dissection
20
20
Myocardial Infarction
20
20
Anemia
20
20
Paralysis
20
20
Respiratory Distress
19
19
Transient Ischemic Attack
18
18
Inflammation
18
18
Atrial Flutter
15
15
Neurological Deficit/Dysfunction
15
15
Cardiogenic Shock
15
15
Pleural Effusion
13
13
Atrial Fibrillation
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
13
13
Test Result
12
12
Respiratory Failure
12
12
Paresis
12
12
Loss of consciousness
12
12
Dizziness
11
11
Nerve Damage
11
11
Fever
11
11
Heart Block
11
11
Foreign Body In Patient
10
10
Vaso-Vagal Response
10
10
Vasoconstriction
10
10
Great Vessel Perforation
9
9
Pneumothorax
9
9
Ventricular Tachycardia
9
9
Hemoptysis
9
9
Edema
9
9
Pulmonary Embolism
8
8
Exit Block
8
8
Cardiopulmonary Arrest
7
7
Laceration(s)
7
7
Sepsis
7
7
Shock
7
7
Vomiting
7
7
Thrombus
6
6
Infarction, Cerebral
6
6
Confusion/ Disorientation
6
6
Palpitations
5
5
Cough
5
5
Mitral Valve Insufficiency/ Regurgitation
5
5
Tricuspid Valve Insufficiency/ Regurgitation
5
5
Intimal Dissection
5
5
Bacterial Infection
5
5
Aneurysm
5
5
Mitral Regurgitation
5
5
Nausea
5
5
Muscle Weakness
5
5
Unspecified Infection
5
5
Intracranial Hemorrhage
5
5
Hemothorax
5
5
Occlusion
5
5
Visual Disturbances
5
5
Numbness
5
5
Weakness
4
4
Pneumonia
4
4
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
I
Mar-26-2024
2
Greatbatch Medical
II
Sep-26-2012
3
Medtronic Inc. Cardiac Rhythm Disease Management
II
Sep-12-2011
4
Medtronic Perfusion Systems
II
Sep-22-2021
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