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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 2
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 13
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
CORDIS CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 4
CRUX BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2
VENETEC
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 6

Device Problems
Difficult to remove 1574
No Information 1408
Migration of device or device component 781
Malposition of device 738
No Known Device Problem 595
Detachment of device or device component 404
Unintended movement 387
Fracture 373
No code available 365
Extrusion 330
Failure to advance 265
Detachment of device component 184
Difficult to deploy 177
Deployment issue 150
Failure to deploy 149
Material perforation 146
Failure to expand 134
Occlusion within device 126
Premature deployment 82
Kinked 71
Other (for use when an appropriate device code cannot be identified) 64
Material separation 62
Failure to align 54
Break 50
Device remains implanted 40
Dislodged or dislocated 39
Material puncture 38
Entrapment of device or device component 37
Filter 37
Material deformation 36
Difficult to advance 34
Bent 32
Twisting 31
Misplacement 26
Device, or device fragments remain in patient 23
Positioning Issue 21
Device handling issue 20
Device clogged 19
Device operates differently than expected 19
Inaccurate delivery 17
Implant, removal of 15
Strut fracture 15
Difficult to insert 13
Material frayed 13
Unknown (for use when the device problem is not known) 13
Torn material 10
Improper or incorrect procedure or method 9
Device or device fragments location unknown 9
Packaging issue 9
Material fragmentation 9
Difficult to position 9
Retraction problem 9
Device Difficult to Setup or Prepare 9
Filter break(s) 8
Device Issue 8
Failure to unfold or unwrap 7
Use of Device Issue 7
Difficult to open or close 7
Therapy delivered to incorrect body area 7
Sticking 6
Leak 6
Delivered as unsterile product 6
Filtration issue 6
Foreign material present in device 6
Physical resistance 6
Malfunction 5
Device, removal of (non-implant) 5
Tears, rips, holes in device, device material 5
Material erosion 5
Dislodged 5
Failure to capture 5
Failure to Adhere or Bond 4
Component(s), broken 4
Material rupture 4
Component or accessory incompatibility 4
Expulsion 4
Material twisted 4
Defective item 4
Tear, rip or hole in device packaging 4
Failure to deliver 3
Material Distortion 3
Device markings issue 3
Material Protrusion 3
Impedance issue 3
Inadequate user interface 3
Device or device component damaged by another device 3
Patient-device incompatibility 3
Buckled material 3
Unsealed device packaging 3
Peeled 3
Displacement 3
Explanted 3
Filter, inadequate 3
Difficult to flush 3
Difficult to fold or unfold 2
Collapse 2
Disconnection 2
Degraded 2
Mechanical issue 2
Instruction for use issue 2
Total Device Problems 9479

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 0 0 0 0
Class II 2 0 0 0 0 0 1 0 0 2 0
Class III 1 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 B. Braun Interventional Systems II Nov-24-2007
2 Bard Peripheral Vascular Inc II Mar-08-2016
3 Bard Peripheral Vascular Inc II Feb-01-2016
4 Bard Peripheral Vascular Inc II Feb-01-2007
5 Boston Scientific III May-10-2007
6 Cordis Corporation II Oct-25-2013
7 Cordis Corporation I Aug-07-2013

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