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TPLC
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Device
filter, intravascular, cardiovascular
Regulation Description
Cardiovascular intravascular filter.
Product Code
DTK
Regulation Number
870.3375
Device Class
2
Premarket Reviews
Manufacturer
Decision
ALN S.A.R.L.
SUBSTANTIALLY EQUIVALENT
1
ARGON MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
B. BRAUN MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
BD
SUBSTANTIALLY EQUIVALENT
1
WILLIAM COOK EUROPE APS
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2020
5404
5404
2021
5357
5516
2022
2191
2196
2023
584
584
2024
406
406
2025
190
190
Device Problems
MDRs with this Device Problem
Events in those MDRs
Structural Problem
4475
4475
Device Tipped Over
2296
2296
Unintended Movement
1824
1823
Difficult to Remove
1789
1796
Appropriate Term/Code Not Available
1752
1752
Insufficient Information
1414
1414
Detachment of Device or Device Component
1390
1395
Malposition of Device
1373
1423
Obstruction of Flow
1145
1145
Patient Device Interaction Problem
1072
1123
Patient-Device Incompatibility
1067
1166
Adverse Event Without Identified Device or Use Problem
961
961
Fracture
775
775
Migration
686
688
Migration or Expulsion of Device
541
543
Positioning Problem
524
526
Activation Failure
308
308
Inadequate Filtration Process
304
304
Failure to Align
285
285
Material Deformation
227
229
Failure to Advance
159
159
Entrapment of Device
129
129
Improper or Incorrect Procedure or Method
115
115
Break
106
106
Therapeutic or Diagnostic Output Failure
103
103
Difficult or Delayed Activation
100
100
Activation, Positioning or Separation Problem
74
74
Material Perforation
59
59
Difficult to Advance
53
53
Material Puncture/Hole
48
48
Material Twisted/Bent
47
47
Deformation Due to Compressive Stress
45
45
Device Dislodged or Dislocated
44
44
Premature Activation
43
43
Difficult to Insert
39
39
Activation Problem
39
39
Defective Device
34
34
Positioning Failure
34
34
Physical Resistance/Sticking
33
33
Failure to Unfold or Unwrap
30
30
Retraction Problem
23
23
Difficult to Open or Close
21
21
Output Problem
19
19
Material Split, Cut or Torn
18
18
Off-Label Use
16
16
Loss of or Failure to Bond
12
12
Complete Blockage
11
11
Device Contamination with Chemical or Other Material
11
11
Device Misassembled During Manufacturing /Shipping
11
11
Difficult or Delayed Separation
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation of Vessels
4813
4813
Internal Organ Perforation
2923
2923
No Clinical Signs, Symptoms or Conditions
1952
2117
Insufficient Information
1740
1740
Perforation
1591
1591
No Information
1572
1572
Pain
1339
1339
Anxiety
1268
1268
Abdominal Pain
954
954
No Consequences Or Impact To Patient
925
925
Thrombosis/Thrombus
918
918
Pulmonary Embolism
840
841
Device Embedded In Tissue or Plaque
675
675
Depression
562
562
Stenosis
499
499
Thrombosis
410
410
Vessel Or Plaque, Device Embedded In
379
379
Dyspnea
347
347
Coagulation Disorder
326
326
Chest Pain
326
326
Occlusion
323
323
Obstruction/Occlusion
309
309
Great Vessel Perforation
238
238
Foreign Body In Patient
187
187
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
162
162
Thrombus
151
151
No Known Impact Or Consequence To Patient
140
140
Injury
131
131
Discomfort
124
124
Hemorrhage/Bleeding
123
123
Death
113
113
Failure of Implant
113
113
Numbness
112
112
Swelling/ Edema
109
109
Distress
98
98
Unspecified Tissue Injury
85
84
Ambulation Difficulties
79
79
Emotional Changes
70
70
Cardiac Perforation
68
68
No Code Available
60
60
Bowel Perforation
54
54
Swelling
53
53
Unspecified Mental, Emotional or Behavioural Problem
47
47
Fatigue
43
43
Cognitive Changes
37
37
Embolism/Embolus
35
35
Thromboembolism
33
33
Sleep Dysfunction
31
31
Peripheral Edema
31
31
Hematoma
30
30
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Jul-27-2023
2
Cook Medical Incorporated
III
Apr-06-2022
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