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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent, ureteral
Regulation Description Ureteral stent.
Product CodeFAD
Regulation Number 876.4620
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIOVNA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 7
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL ENGINEERING CORP.
  SUBSTANTIALLY EQUIVALENT 5
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 8
NORTH AMERICAN STERILIZATION & PACKAGING CO.
  SUBSTANTIALLY EQUIVALENT 1
SURGITEK
  SUBSTANTIALLY EQUIVALENT 9

Device Problems
Break 117
Material separation 74
Calcified 57
Difficult to remove 51
Tears, rips, holes in device, device material 38
Component(s), broken 25
Torn material 24
Migration of device or device component 22
Kinked 16
Detachment of device component 16
No Known Device Problem 14
Device damaged prior to use 13
Knotted 11
Occlusion within device 10
Other (for use when an appropriate device code cannot be identified) 9
Device, removal of (non-implant) 9
Device, or device fragments remain in patient 8
Detachment of device or device component 7
Out-of-box failure 7
Cut in material 7
Tear, rip or hole in device packaging 6
Implant, removal of 6
Blockage within device or device component 6
Difficult to position 5
Unsealed device packaging 5
Elective removal 5
Fracture 5
Device packaging compromised 5
Defective item 5
No Information 5
Patient-device incompatibility 4
Split 4
Device Issue 4
Malfunction 4
Unknown (for use when the device problem is not known) 4
Defective component 4
Replace 4
Difficult to insert 4
Material fragmentation 3
Crack 3
Material perforation 3
Obstruction within device 3
No code available 3
Suture line separation 2
Physical resistance 2
Difficult to advance 2
Dislodged or dislocated 2
Device markings issue 2
Material deformation 2
Disconnection 2
Contamination during use 2
Peeled 2
Source, detachment from 2
Sterility 1
Stretched 1
Device Difficult to Setup or Prepare 1
Device remains implanted 1
Mislabeled 1
Nonstandard device or device component 1
Insulation degradation 1
Material disintegration 1
Bent 1
Biofilm coating in device 1
Material frayed 1
Hole in material 1
Entrapment of device or device component 1
Material erosion 1
Device expiration issue 1
Explanted 1
Filter break(s) 1
No flow 1
Device operates differently than expected 1
Foreign material present in device 1
Incorrect device or component shipped 1
Close, difficult to 1
Malposition of device 1
Folded 1
Folding Issue 1
Failure to deliver 1
Failure to advance 1
Tip breakage 1
Unraveled material 1
Packaging issue 1
Total Device Problems 685

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 3 0 1 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Sep-16-2008
2 Boston Scientific Corporation II May-21-2009
3 Vance Products Incorporated II Jun-25-2015
4 Vance Products Incorporated II Jan-05-2011
5 Vance Products Incorporated II Feb-10-2009
6 Vance Products Incorporated II Jan-23-2009

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