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Device
dilator, vessel, for percutaneous catheterization
Regulation Description
Vessel dilator for percutaneous catheterization.
Product Code
DRE
Regulation Number
870.1310
Device Class
2
Premarket Reviews
Manufacturer
Decision
BAYLIS MEDICAL COMPANY INC.
SUBSTANTIALLY EQUIVALENT
3
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
MEDRON, LLC
SUBSTANTIALLY EQUIVALENT
1
MERIT MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
SPECTRANETICS INC.
SUBSTANTIALLY EQUIVALENT
1
SPECTRANETICS, INC.
SUBSTANTIALLY EQUIVALENT
1
TOGO MEDIKIT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
XCARDIA INNOVATION LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
120
120
2021
115
1579
2022
136
136
2023
392
392
2024
325
325
2025
34
34
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
399
1131
Fracture
133
133
Detachment of Device or Device Component
99
99
Material Separation
97
97
Physical Resistance/Sticking
96
218
Device-Device Incompatibility
83
83
Difficult to Remove
74
74
Defective Device
66
66
Positioning Problem
55
55
Break
55
177
Material Deformation
50
50
Difficult to Advance
50
50
Entrapment of Device
32
32
Material Integrity Problem
23
23
Material Perforation
18
18
Device Contamination with Chemical or Other Material
16
16
Unraveled Material
11
11
Material Frayed
10
10
Component or Accessory Incompatibility
9
9
Display or Visual Feedback Problem
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Material Split, Cut or Torn
8
8
Sharp Edges
8
8
Mechanical Jam
7
373
Loss of or Failure to Bond
7
7
Material Twisted/Bent
7
7
Use of Device Problem
6
6
Failure to Advance
6
6
Fluid/Blood Leak
6
6
Device Damaged by Another Device
6
6
Failure to Cut
5
127
Material Fragmentation
5
5
Deformation Due to Compressive Stress
5
5
Device Dislodged or Dislocated
5
5
Insufficient Information
5
5
Migration
4
4
Difficult to Insert
4
4
Unsealed Device Packaging
4
4
Crack
4
4
Device Contaminated During Manufacture or Shipping
4
4
Tear, Rip or Hole in Device Packaging
4
4
Leak/Splash
4
4
Mechanics Altered
3
125
Partial Blockage
3
3
Mechanical Problem
3
3
Unintended Movement
3
3
Retraction Problem
3
3
Component Missing
3
3
Difficult to Open or Remove Packaging Material
3
3
Separation Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
383
993
Pericardial Effusion
164
408
Foreign Body In Patient
126
248
Low Blood Pressure/ Hypotension
108
108
Great Vessel Perforation
94
338
Perforation of Vessels
79
689
Cardiac Perforation
74
74
Cardiac Tamponade
68
68
Thrombosis/Thrombus
63
63
Hemorrhage/Bleeding
33
33
Device Embedded In Tissue or Plaque
32
32
No Consequences Or Impact To Patient
29
29
Iatrogenic Source
26
148
Insufficient Information
24
24
No Known Impact Or Consequence To Patient
22
22
Hematoma
19
19
Perforation
18
18
Air Embolism
17
17
Cardiac Arrest
16
16
Death
13
135
Non specific EKG/ECG Changes
12
12
Laceration(s)
11
11
Arrhythmia
10
10
Vascular Dissection
10
10
Bradycardia
8
8
Atrial Perforation
7
7
Pain
7
7
Pleural Effusion
6
6
Retroperitoneal Hemorrhage
6
6
Heart Block
6
6
Asystole
6
6
Tachycardia
5
5
Tricuspid Valve Insufficiency/ Regurgitation
5
5
Ischemia
4
4
Myocardial Infarction
4
4
Pneumothorax
4
4
Stroke/CVA
3
3
Pulmonary Embolism
3
3
Thromboembolism
3
3
No Patient Involvement
3
3
Pseudoaneurysm
3
3
Ventricular Fibrillation
3
3
Vasoconstriction
3
3
High Blood Pressure/ Hypertension
3
3
Hypoxia
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Diminished Pulse Pressure
2
2
Cusp Tear
2
2
Rupture
2
2
Hemothorax
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
Angiodynamics, Inc.
II
Mar-21-2024
2
Argon Medical Devices, Inc
II
Aug-14-2020
3
Cardiac Assist, Inc
II
Apr-23-2021
4
Cordis Corporation
II
Jul-15-2021
5
Maquet Cardiovascular Us Sales, Llc
II
Mar-27-2020
6
Merit Medical Systems, Inc.
II
Sep-20-2024
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