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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, vascular, for promoting embolization
Regulation Description Vascular embolization device.
Product CodeKRD
Regulation Number 870.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 13
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 13
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 15
NFOCUS NEUROMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RJ Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 158
Failure to separate 90
No Known Device Problem 74
Failure to advance 72
Migration of device or device component 68
Premature deployment 52
Detachment of device or device component 52
Deployment issue 47
Device Issue 44
Break 44
Stretched 41
Physical resistance 33
Other (for use when an appropriate device code cannot be identified) 30
Material Protrusion 30
Entrapment of device or device component 28
Difficult to remove 26
Failure to deploy 19
Material separation 17
Difficult to position 15
Unraveled material 14
Difficult to advance 13
Difficult to deploy 12
Fracture 12
Kinked 11
Difficult to insert 10
Dislodged or dislocated 10
Unknown (for use when the device problem is not known) 9
Device, or device fragments remain in patient 9
Component missing 6
Material deformation 5
Malposition of device 5
Device remains implanted 5
Device-device incompatibility 5
Positioning Issue 4
Unintended movement 4
Device damaged prior to use 4
Sticking 4
Use of Device Issue 3
Malfunction 3
Device or device fragments location unknown 3
Foreign material present in device 3
Device or device component damaged by another device 3
Uncoiled 3
Failure to expand 3
Shelf life exceeded 2
Reaction 2
Displacement 2
Delivery system failure 2
Wire(s), breakage of 2
Bacterial contamination of device 2
Defective component 1
Tear, rip or hole in device packaging 1
Incomplete or missing packaging 1
Failure to deliver 1
Inaccurate delivery 1
Buckled material 1
Delamination 1
Device, removal of (non-implant) 1
Difficult or delayed activation 1
Device markings issue 1
Device operates differently than expected 1
Material integrity issue 1
Material fragmentation 1
Misplacement 1
Unsealed device packaging 1
Peeled 1
Bent 1
Disconnection 1
Dislodged 1
Component(s), broken 1
Contamination during use 1
Knotted 1
Magnetic interference 1
User used incorrect product for intended use 1
Material puncture 1
Therapy delivered to incorrect body area 1
Spring loading mechanism problem 1
Retraction problem 1
Device handling issue 1
Total Device Problems 1144

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

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012
2 Stryker Neurovascular II Dec-13-2013

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