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TPLC
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show TPLC since
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Device
wire, guide, catheter
Regulation Description
Catheter guide wire.
Product Code
DQX
Regulation Number
870.1330
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT
SUBSTANTIALLY EQUIVALENT
5
ABBOTT LABORATORIES
SUBSTANTIALLY EQUIVALENT
5
ACCELLENT INC
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES INC.
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
ASAHI
SUBSTANTIALLY EQUIVALENT
11
ASAHI INTECC CO., LTD.
SUBSTANTIALLY EQUIVALENT
11
BOSTON SCIENTIFIC
SUBSTANTIALLY EQUIVALENT
1
BOSTON SCIENTIFIC CORP.
SUBSTANTIALLY EQUIVALENT
6
BOSTON SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
4
BOSTON SCIENTIFIC INC.
SUBSTANTIALLY EQUIVALENT
1
CONCERT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
COOK, INC.
SUBSTANTIALLY EQUIVALENT
11
HERAEUS MEDICAL COMPONENTS, LLC
SUBSTANTIALLY EQUIVALENT
2
LAKE REGION MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
6
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
SUBSTANTIALLY EQUIVALENT
2
NANO4IMAGING GMBH
SUBSTANTIALLY EQUIVALENT
2
OPSENS INC.
SUBSTANTIALLY EQUIVALENT
1
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
TERUMO CARDIOVASCULAR SYSTEMS
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS, INC
SUBSTANTIALLY EQUIVALENT
1
VASCULAR SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
5
VOLCANO CORPORATION
SUBSTANTIALLY EQUIVALENT
2
WILLIAM COOK
SUBSTANTIALLY EQUIVALENT
1
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
1463
1463
2017
1523
1523
2018
1733
1733
2019
1677
1677
2020
1480
1480
Device Problems
MDRs with this Device Problem
Events in those MDRs
Difficult to Remove
1104
1104
Break
1030
1030
Material Separation
910
910
Detachment Of Device Component
893
893
Peeled/Delaminated
700
700
Adverse Event Without Identified Device or Use Problem
596
596
Fracture
590
590
Detachment of Device or Device Component
589
589
Guidewire
579
579
Entrapment of Device
551
551
Tip
457
457
Difficult to Advance
331
331
Stretched
327
327
Failure to Advance
326
326
Material Deformation
313
313
Material Integrity Problem
253
253
Improper or Incorrect Procedure or Method
228
228
Wire
219
219
Unraveled Material
182
182
Difficult To Position
162
162
Kinked
135
135
Insufficient Information
122
122
Flaked
117
117
Material Fragmentation
115
115
Deformation Due to Compressive Stress
104
104
Device Damaged by Another Device
103
103
Physical Resistance
101
101
Physical Resistance/Sticking
90
90
Material Split, Cut or Torn
88
88
Material Twisted/Bent
83
83
Device Operates Differently Than Expected
80
80
Material Frayed
75
75
Positioning Problem
69
69
Product Quality Problem
64
64
Device Damaged Prior to Use
59
59
Off-Label Use
56
56
Material Protrusion/Extrusion
53
53
Bent
44
44
Catheter
40
40
Device Contamination with Chemical or Other Material
39
39
Difficult to Insert
35
35
Occlusion Within Device
35
35
Material Too Soft/Flexible
34
34
Delamination
33
33
Device Dislodged or Dislocated
33
33
Physical Property Issue
31
31
Torn Material
30
30
Unsealed Device Packaging
30
30
Contamination /Decontamination Problem
27
27
Leak/Splash
25
25
Uncoiled
24
24
Appropriate Term/Code Not Available
23
23
Sticking
22
22
Device Markings/Labelling Problem
21
21
Defective Device
21
21
Fluid Leak
21
21
Mechanical Problem
18
18
Use of Device Problem
17
17
Activation, Positioning or SeparationProblem
16
16
Retraction Problem
15
15
Material Too Rigid or Stiff
14
14
Device Misassembled During Manufacturing /Shipping
14
14
Device Displays Incorrect Message
11
11
Split
11
11
Crack
11
11
Device Or Device Fragments Location Unknown
10
10
Material Distortion
10
10
Difficult or Delayed Positioning
10
10
Structural Problem
9
9
Material Perforation
9
9
Collapse
9
9
Migration or Expulsion of Device
8
8
Filter
8
8
Scratched Material
8
8
Partial Blockage
7
7
Malposition of Device
7
7
Connection Problem
7
7
Component Missing
7
7
Separation Failure
7
7
Cut In Material
6
6
Communication or Transmission Problem
6
6
Device Difficult to Setup or Prepare
6
6
Mechanical Jam
6
6
Packaging Problem
6
6
Defective Component
6
6
Disconnection
6
6
Knotted
5
5
Balloon
5
5
Coil
5
5
Core
5
5
Unable to Obtain Readings
5
5
Tear, Rip or Hole in Device Packaging
5
5
Device-Device Incompatibility
5
5
Compatibility Problem
5
5
Component Misassembled
5
5
Material Torqued
5
5
Human-Device Interface Problem
5
5
Device Issue
5
5
Component or Accessory Incompatibility
4
4
Patient-Device Incompatibility
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
3643
3643
No Known Impact Or Consequence To Patient
1002
1002
Device Embedded In Tissue or Plaque
979
979
Foreign Body In Patient
534
534
No Patient Involvement
405
405
Vessel Or Plaque, Device Embedded In
242
242
Death
194
194
Perforation
166
166
No Clinical Signs, Symptoms or Conditions
165
165
No Code Available
146
146
Perforation of Vessels
137
137
Vascular Dissection
114
114
No Information
103
103
Pericardial Effusion
99
99
Intimal Dissection
96
96
Cardiac Tamponade
94
94
Low Blood Pressure/ Hypotension
75
75
Cardiac Perforation
74
74
Patient Problem/Medical Problem
53
53
Blood Loss
45
45
Occlusion
42
42
Embolism
39
39
Hemorrhage/Bleeding
39
39
Cardiac Arrest
34
34
Thrombosis
30
30
Stroke/CVA
29
29
Myocardial Infarction
27
27
Hematoma
23
23
Headache
21
21
Arrhythmia
20
20
Injury
20
20
Rupture
20
20
Thrombus
19
19
Angina
19
19
Vasoconstriction
18
18
Insufficient Information
17
17
Pain
17
17
Tissue Damage
17
17
Unspecified Infection
16
16
Calcium Deposits/Calcification
14
14
Chest Pain
13
13
Embolus
12
12
Aneurysm
12
12
Ischemia
11
11
Hemorrhage, Subarachnoid
11
11
Laceration(s)
10
10
Bradycardia
10
10
Intracranial Hemorrhage
10
10
High Blood Pressure/ Hypertension
10
10
Inflammation
9
9
Complete Heart Block
9
9
Aortic Dissection
9
9
Cardiogenic Shock
9
9
Stenosis
9
9
Obstruction/Occlusion
9
9
Non specific EKG/ECG Changes
8
8
Cardiopulmonary Arrest
7
7
Mitral Regurgitation
7
7
Respiratory Failure
7
7
Pseudoaneurysm
7
7
Ventricular Fibrillation
7
7
Bone Fracture(s)
7
7
Pleural Effusion
6
6
Internal Organ Perforation
6
6
Not Applicable
6
6
ST Segment Elevation
6
6
Sepsis
6
6
Swelling
6
6
Hemorrhage, Cerebral
6
6
Dyspnea
5
5
Neurological Deficit/Dysfunction
5
5
Pneumothorax
5
5
Atrial Fibrillation
5
5
Syncope
5
5
Infarction, Cerebral
4
4
Hemoptysis
4
4
Respiratory Distress
4
4
Discomfort
4
4
Air Embolism
4
4
Extravasation
4
4
Hypersensitivity/Allergic reaction
4
4
Ventricular Tachycardia
4
4
Transient Ischemic Attack
4
4
Atrial Perforation
4
4
Thrombosis/Thrombus
4
4
Visual Disturbances
3
3
Heart Failure
3
3
Loss Of Pulse
3
3
Vascular System (Circulation), Impaired
3
3
Hemothorax
3
3
Hypoxia
2
2
Fistula
2
2
Paralysis
2
2
Abdominal Pain
2
2
Anaphylactic Shock
2
2
Alteration In Body Temperature
2
2
Test Result
2
2
Diminished Pulse Pressure
2
2
Shock
2
2
Tachycardia
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Anewmed Corporation
II
Oct-31-2019
2
Argon Medical Devices, Inc
I
May-07-2020
3
Arrow International Inc
II
Jan-23-2020
4
Arrow International Inc
II
May-30-2018
5
Arrow International Inc
II
Apr-10-2018
6
Arrow International Inc
II
Apr-02-2018
7
Arrow International Inc
II
Jun-12-2017
8
Arrow International Inc
II
Sep-07-2016
9
Arrow International Inc
II
Jul-12-2016
10
Boston Scientific Corporation
II
Feb-20-2019
11
Boston Scientific Corporation
II
Apr-12-2016
12
Cook Inc.
I
Nov-03-2020
13
Cook Inc.
II
Mar-09-2018
14
Cook Inc.
I
Aug-25-2016
15
Micro Therapeutics Inc, Dba Ev3 Neurovascular
I
Nov-09-2016
16
SentreHeart Inc
I
Nov-09-2016
17
Stryker Neurovascular
II
Oct-29-2019
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