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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, tracheal, expandable
Regulation Description Tracheal prosthesis.
Product CodeJCT
Regulation Number 878.3720
Device Class 2


Premarket Reviews
ManufacturerDecision
ALVEOLUS, INC
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 3
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SE SUBJECT TO TRACKING REG 6
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
SULZER
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR ARCHITECTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Failure to deploy 168
Fracture 98
No code available 90
Other (for use when an appropriate device code cannot be identified) 51
Difficult to deploy 39
Deployment issue 32
Break 28
Positioning Issue 25
Suture line separation 24
Detachment of device component 23
Difficult to remove 18
Kinked 17
Migration of device or device component 16
Component(s), broken 15
Occlusion within device 14
Leak 9
Knotted 8
Failure to expand 8
Premature deployment 7
Difficult to position 6
Device damaged prior to use 6
Implant, removal of 5
Device Issue 5
Physical resistance 5
Bent 5
Device remains implanted 4
Malposition of device 4
Failure to advance 4
No Known Device Problem 4
Detachment of device or device component 3
Fitting problem 3
Material perforation 3
Suture line disruption 3
Size incorrect for patient 3
Looping 3
Misplacement 3
Collapse 3
Explanted 3
Blockage within device or device component 2
Dislodged 2
Misassembled 2
Retraction problem 2
Unknown (for use when the device problem is not known) 2
Tears, rips, holes in device, device material 2
Tip breakage 2
Unraveled material 2
Failure to unfold or unwrap 1
Component missing 1
Cut in material 1
Failure to deliver 1
Wire(s), breakage of 1
Device packaging compromised 1
Difficult to advance 1
Dislodged or dislocated 1
Material twisted 1
Implant breakage or physical damage 1
Shaft break 1
Source, detachment from 1
Sterility 1
Sticking 1
Peeled 1
Device expiration issue 1
Flaked 1
Difficult to flush 1
Handpiece break 1
Handpiece detachment 1
Hole in material 1
Total Device Problems 802

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

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-15-2011
2 Boston Scientific Corporation II Aug-31-2010
3 Boston Scientific Corporation II Jun-25-2010

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