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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, intravascular, cardiovascular
Regulation Description Cardiovascular intravascular filter.
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
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
2021 5357 5516
2022 2191 2196
2023 583 583
2024 406 406
2025 438 438

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 3567 3567
Device Tipped Over 1736 1736
Appropriate Term/Code Not Available 1403 1403
Unintended Movement 1253 1252
Difficult to Remove 1011 1018
Detachment of Device or Device Component 1009 1014
Obstruction of Flow 894 894
Patient-Device Incompatibility 867 966
Malposition of Device 702 752
Fracture 437 437
Migration 365 367
Adverse Event Without Identified Device or Use Problem 339 339
Patient Device Interaction Problem 292 343
Activation Failure 283 283
Inadequate Filtration Process 220 220
Insufficient Information 199 199
Migration or Expulsion of Device 176 178
Positioning Problem 161 163
Failure to Advance 159 159
Material Deformation 152 154
Improper or Incorrect Procedure or Method 101 101
Break 81 81
Therapeutic or Diagnostic Output Failure 73 73
Difficult or Delayed Activation 67 67
Activation, Positioning or Separation Problem 53 53
Deformation Due to Compressive Stress 51 51
Material Puncture/Hole 49 49
Entrapment of Device 48 48
Difficult to Advance 46 46
Premature Activation 44 44
Activation Problem 43 43
Difficult to Insert 43 43
Device Dislodged or Dislocated 39 39
Failure to Unfold or Unwrap 38 38
Material Twisted/Bent 36 36
Material Perforation 34 34
Positioning Failure 32 32
Physical Resistance/Sticking 27 27
Failure to Align 25 25
Defective Device 21 21
Retraction Problem 20 20
Material Split, Cut or Torn 20 20
Output Problem 19 19
Difficult to Open or Close 17 17
Off-Label Use 16 16
Device Contamination with Chemical or Other Material 13 13
Loss of or Failure to Bond 12 12
Device Misassembled During Manufacturing /Shipping 11 11
Material Frayed 11 11
Complete Blockage 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 3224 3224
Internal Organ Perforation 2216 2216
No Clinical Signs, Symptoms or Conditions 1809 1974
Insufficient Information 1738 1738
Anxiety 985 985
Thrombosis/Thrombus 873 873
Pain 860 860
Perforation 684 684
Abdominal Pain 580 580
Device Embedded In Tissue or Plaque 562 562
Depression 461 461
Pulmonary Embolism 435 435
Stenosis 353 353
No Information 329 329
Obstruction/Occlusion 245 245
Dyspnea 240 240
Chest Pain 200 200
Foreign Body In Patient 169 169
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 166 166
Coagulation Disorder 147 147
Occlusion 128 128
No Consequences Or Impact To Patient 126 126
Discomfort 112 112
Hemorrhage/Bleeding 107 107
Swelling/ Edema 103 103
Great Vessel Perforation 95 95
Numbness 90 90
Unspecified Tissue Injury 85 84
Distress 65 65
Ambulation Difficulties 65 65
Emotional Changes 57 57
Failure of Implant 46 46
Unspecified Mental, Emotional or Behavioural Problem 40 40
Cardiac Perforation 40 40
Embolism/Embolus 37 37
Bowel Perforation 36 36
Fatigue 34 34
Cognitive Changes 33 33
Peripheral Edema 30 30
Sleep Dysfunction 27 27
Foreign Body Embolism 26 26
Loss of Vision 24 24
Cramp(s) /Muscle Spasm(s) 22 22
Dizziness 21 21
Hematoma 21 21
Nausea 20 20
Headache 16 16
Injury 16 16
Stroke/CVA 15 15
Muscle Weakness 14 14

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Nov-24-2025
2 Argon Medical Devices, Inc II Jul-27-2023
3 Cook Medical Incorporated III Apr-06-2022
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