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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device device, neurovascular embolization
Regulation Description Neurovascular embolization device.
Product CodeHCG
Regulation Number 882.5950
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOCURE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 20
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 13
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 11
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 31
MICRUS
  SUBSTANTIALLY EQUIVALENT 16
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 6
RJ Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SCION CARDIO-VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICA CORP.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
No Known Device Problem 961
Physical resistance 664
Stretched 664
Failure to advance 640
Other (for use when an appropriate device code cannot be identified) 570
Detachment of device component 531
Premature deployment 521
Failure to deploy 358
Break 340
Unraveled material 260
Kinked 220
Migration of device or device component 185
Difficult to advance 150
Mechanical jam 138
Device Issue 117
Device handling issue 110
No code available 107
Failure to separate 92
Device operates differently than expected 88
Bent 86
Unknown (for use when the device problem is not known) 70
Difficult to position 69
Retraction problem 66
Fracture 65
Material separation 60
Deployment issue 57
Out-of-box failure 53
Delivery system failure 51
Device damaged prior to use 50
Detachment of device or device component 43
Difficult to remove 38
Malposition of device 35
Entrapment of device or device component 33
Difficult to deploy 31
Buckled material 31
Material deformation 30
Material Protrusion 30
Mechanical issue 29
Occlusion within device 29
Positioning Issue 28
Device Difficult to Setup or Prepare 23
Leak 22
Air leak 22
Crack 21
Device, or device fragments remain in patient 21
Size incorrect for patient 21
Device or device component damaged by another device 17
No Information 16
Difficult or delayed activation 15
Material rupture 15
Use of Device Issue 15
Device, removal of (non-implant) 13
Device remains implanted 11
Device-device incompatibility 10
Not Applicable 9
Component(s), broken 9
Lens, repositioning of 9
Knotted 8
Unintended movement 8
Structural problem 8
Device markings issue 7
Therapeutic or diagnostic output failure 7
Dislodged or dislocated 7
Foreign material present in device 6
Patient-device incompatibility 6
Difficult to insert 6
Failure to fold 6
Blockage within device or device component 5
Material disintegration 5
Difficult to fold or unfold 5
Unable to confirm conditions of use 5
Failure to disconnect 5
Inaccurate delivery 5
Material integrity issue 5
Torn material 4
Component missing 4
Defective item 4
Device or device fragments location unknown 4
Connection issue 4
Sticking 4
Component falling 4
Contamination during use 3
Failure to flush 3
Improper or incorrect procedure or method 3
Slippage of device or device component 3
Unsealed device packaging 3
Peeled 3
Delivery System Issue, No Description 3
Packaging issue 3
Material Distortion 2
Incorrect device or component shipped 2
Material perforation 2
Seal, defective 2
Bacterial contamination of device 2
Failure to prime 2
Material rigid or stiff 2
Uncoiled 2
Interference 2
Material frayed 2
Looping 2
Total Device Problems 8147

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Target II Mar-29-2007
2 Cook, Inc. III Sep-16-2008
3 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-26-2012
4 Micro Therapeutics Inc, dba ev3 Neurovascular III Jan-24-2012
5 Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 II Jan-03-2011
6 Penumbra Inc. I Apr-12-2011
7 Stryker Neurovascular II Jul-11-2016
8 Stryker Neurovascular II Apr-19-2016
9 Stryker Neurovascular II Dec-16-2014
10 Stryker Neurovascular II Dec-13-2013

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