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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 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
2019
6467
6474
2020
5404
5404
2021
5357
5516
2022
2191
2196
2023
584
584
2024
374
374
Device Problems
MDRs with this Device Problem
Events in those MDRs
Structural Problem
4712
4712
Insufficient Information
4035
4035
Appropriate Term/Code Not Available
4015
4015
Difficult to Remove
2985
2993
Device Tipped Over
2430
2430
Malposition of Device
2223
2275
Unintended Movement
2027
2026
Patient Device Interaction Problem
1879
1932
Detachment of Device or Device Component
1807
1817
Adverse Event Without Identified Device or Use Problem
1470
1470
Obstruction of Flow
1334
1334
Fracture
1302
1302
Patient-Device Incompatibility
1277
1378
Migration or Expulsion of Device
1010
1013
Migration
992
994
Failure to Align
974
974
Positioning Problem
590
592
Inadequate Filtration Process
331
331
Activation Failure
306
306
Entrapment of Device
290
290
Material Deformation
284
286
Failure to Advance
146
146
Therapeutic or Diagnostic Output Failure
123
123
Break
115
115
Difficult or Delayed Activation
110
110
Improper or Incorrect Procedure or Method
103
103
Activation, Positioning or Separation Problem
99
99
Material Perforation
86
86
Material Twisted/Bent
78
78
Difficult to Advance
57
57
Material Puncture/Hole
55
55
Activation Problem
49
49
Defective Device
49
49
Premature Activation
46
46
Device Dislodged or Dislocated
42
42
Deformation Due to Compressive Stress
42
42
Difficult to Insert
41
41
Physical Resistance/Sticking
35
35
Positioning Failure
34
34
Failure to Unfold or Unwrap
26
26
Defective Component
25
25
Retraction Problem
24
24
Difficult to Open or Close
22
22
Output Problem
21
21
Material Split, Cut or Torn
20
20
Complete Blockage
16
16
Material Separation
15
15
Difficult or Delayed Positioning
13
13
Off-Label Use
12
12
Unexpected Therapeutic Results
11
11
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Perforation of Vessels
7501
7501
No Information
4210
4210
Internal Organ Perforation
3941
3941
Perforation
2168
2168
Pain
2113
2113
No Clinical Signs, Symptoms or Conditions
2001
2173
Anxiety
1816
1816
Insufficient Information
1721
1721
No Consequences Or Impact To Patient
1570
1577
Pulmonary Embolism
1421
1422
Abdominal Pain
1307
1307
Thrombosis
1094
1094
Thrombosis/Thrombus
948
948
Vessel Or Plaque, Device Embedded In
925
925
Device Embedded In Tissue or Plaque
835
835
Depression
697
697
Stenosis
680
680
Occlusion
652
652
Coagulation Disorder
522
522
Dyspnea
482
482
Chest Pain
482
482
No Code Available
419
419
Thrombus
394
394
Obstruction/Occlusion
330
330
Injury
301
301
No Known Impact Or Consequence To Patient
289
289
Great Vessel Perforation
282
282
Death
258
258
Foreign Body In Patient
204
204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
159
159
Hemorrhage/Bleeding
149
149
Discomfort
145
145
Swelling
142
142
Failure of Implant
137
137
Numbness
135
135
Swelling/ Edema
115
115
Cardiac Perforation
105
105
Distress
102
102
Ambulation Difficulties
96
96
Embolus
95
95
Emotional Changes
94
94
Unspecified Tissue Injury
85
84
Bowel Perforation
82
82
Fatigue
64
64
Thromboembolism
57
57
Hematoma
56
56
Unspecified Mental, Emotional or Behavioural Problem
47
47
Disability
44
44
Nausea
39
39
Cognitive Changes
39
39
Recalls
Manufacturer
Recall Class
Date Posted
1
Argon Medical Devices, Inc
II
Jul-27-2023
2
Cook Medical Incorporated
III
Apr-06-2022
3
Cook Medical Incorporated
III
Mar-19-2019
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