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TPLC
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Device
filter, intravascular, cardiovascular
Product Code
DTK
Regulation Number
870.3375
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALN IMPLANTS CHIRURGICAUX
SUBSTANTIALLY EQUIVALENT
2
ALN S.A.R.L.
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
B.BRAUN INTERVENTIONAL SYSTEMS INC.
SUBSTANTIALLY EQUIVALENT
1
BD
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
SUBSTANTIALLY EQUIVALENT
6
COOK INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
CORDIS CORP., A JOHNSON & JOHNSON CO.
SUBSTANTIALLY EQUIVALENT
1
CORDIS, A JOHNSON & JOHNSON CO.
SUBSTANTIALLY EQUIVALENT
1
CRUX BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
2
NOVATE MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
3
REX MEDICAL
SUBSTANTIALLY EQUIVALENT
1
REX MEDICAL LP
SUBSTANTIALLY EQUIVALENT
1
REX MEDICAL, LP
SUBSTANTIALLY EQUIVALENT
1
RMT MEDICAL TECHNILOGIES INC.
SE - WITH LIMITATIONS
1
VOLCANO CORPORATION
SUBSTANTIALLY EQUIVALENT
1
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
10
MDR Year
MDR Reports
MDR Events
2014
451
451
2015
858
858
2016
2576
2576
2017
4364
4364
2018
3938
3938
2019
6467
6474
2020
5404
5404
2021
5357
5516
2022
2191
2196
2023
584
584
2024
283
283
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
8825
8825
Difficult to Remove
6964
6972
Appropriate Term/Code Not Available
6066
6066
Structural Problem
5033
5033
Unintended Movement
3859
3858
Malposition of Device
3841
3893
Adverse Event Without Identified Device or Use Problem
2921
2921
Detachment of Device or Device Component
2645
2655
Device Tipped Over
2595
2595
Migration or Expulsion of Device
2589
2592
Fracture
2500
2500
Patient Device Interaction Problem
2418
2471
Patient-Device Incompatibility
1602
1703
Failure to Align
1589
1589
Obstruction of Flow
1526
1526
Migration
1139
1141
Positioning Problem
695
697
Extrusion
612
612
Activation Failure
504
504
Entrapment of Device
455
455
Failure to Advance
428
428
Material Deformation
418
420
Inadequate Filtration Process
365
365
Activation, Positioning or Separation Problem
321
321
Break
216
216
Material Perforation
186
186
Occlusion Within Device
183
183
Detachment Of Device Component
156
156
Therapeutic or Diagnostic Output Failure
132
132
Positioning Failure
128
128
Difficult or Delayed Positioning
112
112
Difficult or Delayed Activation
111
111
Material Separation
108
108
Difficult to Advance
107
107
Premature Activation
104
104
Improper or Incorrect Procedure or Method
104
104
Material Twisted/Bent
99
99
Material Puncture/Hole
99
99
Device Dislodged or Dislocated
91
91
Kinked
83
83
Device Operates Differently Than Expected
82
82
Bent
62
62
Difficult to Insert
62
62
Defective Device
60
60
Complete Blockage
56
56
Material Fragmentation
56
56
Activation Problem
50
50
Retraction Problem
49
49
Deformation Due to Compressive Stress
47
47
Difficult to Open or Close
43
43
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation of Vessels
10773
10773
No Information
8743
8743
Internal Organ Perforation
5367
5367
Pain
4152
4152
No Consequences Or Impact To Patient
3369
3376
Perforation
3030
3030
Anxiety
2801
2801
Vessel Or Plaque, Device Embedded In
2550
2550
Pulmonary Embolism
2460
2462
Thrombosis
2391
2391
No Clinical Signs, Symptoms or Conditions
2109
2281
No Known Impact Or Consequence To Patient
1837
1837
Abdominal Pain
1824
1824
Insufficient Information
1755
1755
Occlusion
1406
1406
Device Embedded In Tissue or Plaque
1320
1320
Injury
1084
1084
Thrombosis/Thrombus
1070
1070
No Code Available
1053
1053
Chest Pain
1036
1036
Dyspnea
877
877
Stenosis
866
866
Depression
845
845
Thrombus
844
844
Coagulation Disorder
734
734
Great Vessel Perforation
723
723
Death
616
617
Swelling
454
454
Foreign Body In Patient
438
438
Obstruction/Occlusion
371
371
Hemorrhage/Bleeding
325
325
Embolus
258
258
Numbness
191
191
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
186
186
Discomfort
182
182
Blood Loss
181
181
Failure of Implant
153
153
Cardiac Perforation
150
150
Emotional Changes
139
139
Hematoma
138
138
Swelling/ Edema
134
134
Distress
125
125
Ambulation Difficulties
113
113
Embolism
110
110
Bowel Perforation
102
102
Edema
99
99
Vascular System (Circulation), Impaired
95
95
Fatigue
91
91
Unspecified Tissue Injury
86
85
Disability
86
86
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Jul-27-2023
2
Bard Peripheral Vascular Inc
II
Mar-08-2016
3
Bard Peripheral Vascular Inc
II
Feb-01-2016
4
Cook Medical Incorporated
III
Apr-06-2022
5
Cook Medical Incorporated
III
Mar-19-2019
6
Cordis Corporation
II
Oct-25-2013
7
Cordis Corporation
I
Aug-07-2013
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