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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 IMPLANTS CHIRURGICAUX
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 3
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Insufficient Information 7890
Difficult to Remove 5014
Appropriate Term/Code Not Available 4607
Filter 2573
Malposition of device 2328
Unintended Movement 1922
Adverse Event Without Identified Device or Use Problem 1840
Migration or Expulsion of Device 1770
Failure to Align 1505
Fracture 1482
Patient Device Interaction Problem 1469
Detachment of Device or device Component 1166
Extrusion 566
Migration 411
Positioning Problem 371
Failure to Advance 274
Entrapment of Device 224
Structural Problem 224
Obstruction of Flow 188
Activation Failure Including Expansion Failures 188
Activation, Positioning or Separation Problem 157
Occlusion Within Device 156
Material Deformation 129
Device Tipped Over 122
Difficult or Delayed Positioning 97
Material Separation 87
Positioning Failure 82
Kinked 75
Difficult to Advance 61
Detachment Of Device Component 59
Material Puncture / Hole 58
Premature Activation 58
Break 53
Material Twisted / Bent 51
Material Perforation 45
Bent 43
Device Dislodged or Dislocated 42
Complete Blockage 34
Catheter 27
Difficult or Delayed Activation 27
Difficult to Insert 25
Device Handling Problem 23
Retraction Problem 18
Material Frayed 18
Device Operates Differently Than Expected 16
Patient-Device Incompatibility 14
Material Fragmentation 13
Tip 12
Failure to Unfold or Unwrap 11
Material Erosion 11
Device Or Device Fragments Location Unknown 10
Therapy Delivered to Incorrect Body Area 10
Activation Problem 10
Filtration Problem 9
Device Difficult to Setup or Prepare 9
Material Split, Cut or Torn 9
Torn Material 9
Deformation Due to Compressive Stress 8
Device Issue 8
Improper or Incorrect Procedure or Method 8
Difficult to Open or Close 7
Leak / Splash 7
Collapse 7
Inadequate Filtration Process 7
Cannula Guide 6
Crack 6
Split 6
Difficult To Position 6
Material Protrusion / Extrusion 6
Difficult or Delayed Separation 6
Stent 5
Failure to Capture 5
No Apparent Adverse Event 5
Defective Component 5
Use of Device Problem 5
Sticking 5
Physical Resistance 5
Partial Blockage 4
Expulsion 4
Device Contamination with Chemical or Other Material 4
Packaging Problem 4
Component or Accessory Incompatibility 4
Premature Separation 3
Shaft 3
Difficult to Flush 3
Defective Device 3
Tear, Rip or Hole in Device Packaging 3
Device Damaged by Another Device 3
Material Rupture 3
Mechanical Problem 3
Delivered as Unsterile Product 3
Failure To Adhere Or Bond 3
Device Markings / Labelling Problem 3
Device Operational Issue 3
Unsealed Device Packaging 3
Material Distortion 3
Component Missing 2
Sharp Edges 2
Device Slipped 2
Hole In Material 2
Total Device Problems 37895

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Mar-08-2016
2 Bard Peripheral Vascular Inc II Feb-01-2016
3 Cook Medical Incorporated III Mar-19-2019

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