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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 8
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 132
Material separation 80
Difficult to remove 75
Calcified 64
Tears, rips, holes in device, device material 38
Knotted 33
Migration of device or device component 30
Torn material 27
Component(s), broken 25
No Known Device Problem 22
Kinked 21
Occlusion within device 17
Detachment of device component 16
Device damaged prior to use 13
Detachment of device or device component 13
Device, removal of (non-implant) 9
Other (for use when an appropriate device code cannot be identified) 9
Device, or device fragments remain in patient 8
Out-of-box failure 7
Tear, rip or hole in device packaging 7
Cut in material 7
Implant, removal of 6
Fracture 6
Blockage within device or device component 6
No code available 6
No Information 5
Unsealed device packaging 5
Difficult to position 5
Elective removal 5
Split 5
Defective item 5
Device packaging compromised 5
Device operates differently than expected 4
Patient-device incompatibility 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
Stretched 2
Suture line separation 2
Physical resistance 2
Device markings issue 2
Difficult to advance 2
Dislodged or dislocated 2
Foreign material present in device 2
Disconnection 2
Contamination during use 2
Material frayed 2
Entrapment of device or device component 2
Source, detachment from 2
Peeled 2
Packaging issue 2
Material deformation 2
No flow 1
Positioning Issue 1
Unintended movement 1
Device Difficult to Setup or Prepare 1
Device remains implanted 1
Sterility 1
Insulation degradation 1
Mislabeled 1
Nonstandard device or device component 1
Material erosion 1
Device expiration issue 1
Explanted 1
Filter break(s) 1
Hole in material 1
Material disintegration 1
Device clogged 1
Bent 1
Biofilm coating in device 1
Incorrect device or component shipped 1
Buckled material 1
Close, difficult to 1
Malposition of device 1
Folded 1
Folding Issue 1
Tip breakage 1
Unraveled material 1
Failure to advance 1
Failure to deliver 1
Total Device Problems 814

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 3 0 1 0 0 0 1 1 0
Class III 0 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 C.R. Bard, Inc. II Nov-14-2016
4 Vance Products Incorporated II Jun-25-2015
5 Vance Products Incorporated II Jan-05-2011
6 Vance Products Incorporated II Feb-10-2009
7 Vance Products Incorporated II Jan-23-2009

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