• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 933
Stretched 631
Other (for use when an appropriate device code cannot be identified) 570
Failure to advance 541
Physical resistance 525
Premature deployment 488
Detachment of device component 446
Failure to deploy 329
Break 319
Unraveled material 256
Kinked 189
Migration of device or device component 169
Difficult to advance 148
Device Issue 117
Mechanical jam 111
No code available 103
Device handling issue 76
Failure to separate 75
Bent 75
Unknown (for use when the device problem is not known) 70
Device operates differently than expected 67
Fracture 63
Difficult to position 62
Retraction problem 57
Deployment issue 57
Material separation 56
Delivery system failure 51
Out-of-box failure 48
Device damaged prior to use 45
Detachment of device or device component 39
Difficult to remove 37
Malposition of device 34
Entrapment of device or device component 31
Difficult to deploy 29
Occlusion within device 29
Material deformation 29
Material Protrusion 28
Positioning Issue 28
Buckled material 28
Device Difficult to Setup or Prepare 23
Leak 22
Air leak 22
Crack 21
Device, or device fragments remain in patient 21
Mechanical issue 21
Size incorrect for patient 16
Device or device component damaged by another device 16
Material rupture 15
Use of Device Issue 14
No Information 14
Device, removal of (non-implant) 13
Difficult or delayed activation 12
Device remains implanted 11
Component(s), broken 9
Lens, repositioning of 9
Not Applicable 9
Unintended movement 8
Structural problem 8
Knotted 8
Dislodged or dislocated 7
Therapeutic or diagnostic output failure 7
Foreign material present in device 6
Device-device incompatibility 6
Device markings issue 6
Patient-device incompatibility 6
Unable to confirm conditions of use 5
Inaccurate delivery 5
Failure to disconnect 5
Material integrity issue 5
Difficult to insert 5
Difficult to fold or unfold 5
Failure to fold 5
Blockage within device or device component 5
Material disintegration 5
Component falling 4
Sticking 4
Torn material 4
Component missing 4
Connection issue 4
Device or device fragments location unknown 4
Delivery System Issue, No Description 3
Packaging issue 3
Slippage of device or device component 3
Improper or incorrect procedure or method 3
Unsealed device packaging 3
Contamination during use 3
Failure to flush 3
Interference 2
Material frayed 2
Dislodged 2
Electrical issue 2
Failure to discharge 2
Disconnection 2
Coiled 2
Peeled 2
Failure to prime 2
Material perforation 2
Material Distortion 2
Incorrect device or component shipped 2
Uncoiled 2
Total Device Problems 7435

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

-
-