• 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 29
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 812
Other (for use when an appropriate device code cannot be identified) 570
Stretched 565
Premature deployment 373
Break 243
Unraveled material 241
Failure to advance 239
Failure to deploy 236
Physical resistance 196
Detachment of device component 188
Difficult to advance 128
Kinked 124
Migration of device or device component 122
No code available 102
Unknown (for use when the device problem is not known) 70
Fracture 55
Failure to separate 54
Material separation 50
Delivery system failure 50
Deployment issue 50
Difficult to position 35
Device Issue 33
Difficult to remove 32
Occlusion within device 29
Malposition of device 28
Entrapment of device or device component 24
Positioning Issue 24
Bent 24
Detachment of device or device component 23
Out-of-box failure 22
Material Protrusion 22
Leak 22
Device operates differently than expected 22
Retraction problem 22
Difficult to deploy 21
Device, or device fragments remain in patient 21
Crack 21
Device damaged prior to use 21
Device Difficult to Setup or Prepare 20
Buckled material 18
Material deformation 17
Air leak 17
Material rupture 15
No Information 14
Device, removal of (non-implant) 13
Device or device component damaged by another device 12
Device handling issue 12
Device remains implanted 11
Use of Device Issue 11
Not Applicable 9
Lens, repositioning of 9
Component(s), broken 9
Difficult or delayed activation 7
Therapeutic or diagnostic output failure 7
Device markings issue 6
Knotted 6
Unintended movement 6
Difficult to fold or unfold 5
Foreign material present in device 5
Failure to disconnect 5
Inaccurate delivery 5
Dislodged or dislocated 5
Unable to confirm conditions of use 5
Material disintegration 4
Connection issue 4
Device or device fragments location unknown 4
Difficult to insert 4
Device-device incompatibility 4
Size incorrect for patient 4
Sticking 4
Blockage within device or device component 4
Mechanical jam 4
Failure to flush 3
Packaging issue 3
Torn material 3
Component missing 3
Structural problem 3
Delivery System Issue, No Description 3
Material integrity issue 3
Contamination during use 3
Improper or incorrect procedure or method 3
Interference 2
Uncoiled 2
Electrical issue 2
Coiled 2
Mechanical issue 2
Failure to discharge 2
Material perforation 2
Bacterial contamination of device 2
Component falling 2
Disconnection 2
Unsealed device packaging 2
Dislodged 2
Peeled 2
Seal, defective 2
Incorrect device or component shipped 2
Port leak(s) 1
Shaft break 1
Material fragmentation 1
Failure to power-up 1
Total Device Problems 5260

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 1
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 Apr-19-2016
8 Stryker Neurovascular II Dec-16-2014
9 Stryker Neurovascular II Dec-13-2013

-
-