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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 141
Difficult to remove 86
Material separation 85
Calcified 77
Tears, rips, holes in device, device material 38
Knotted 34
Migration of device or device component 33
Torn material 27
Component(s), broken 25
No Known Device Problem 24
Kinked 23
Occlusion within device 16
Detachment of device component 16
Device damaged prior to use 14
Detachment of device or device component 14
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
Tear, rip or hole in device packaging 7
Out-of-box failure 7
Cut in material 7
Device operates differently than expected 7
Fracture 7
Blockage within device or device component 7
Difficult to position 6
Implant, removal of 6
No code available 6
Defective item 5
No Information 5
Stretched 5
Device packaging compromised 5
Split 5
Unsealed device packaging 5
Elective removal 5
Replace 4
Difficult to insert 4
Patient-device incompatibility 4
Unknown (for use when the device problem is not known) 4
Defective component 4
Malfunction 4
Device Issue 4
Obstruction within device 3
Material perforation 3
Material fragmentation 3
Crack 3
Foreign material present in device 3
Material deformation 2
Packaging issue 2
Disconnection 2
Contamination during use 2
Material frayed 2
Entrapment of device or device component 2
Source, detachment from 2
Peeled 2
Suture line separation 2
Device markings issue 2
Difficult to advance 2
Dislodged or dislocated 2
Physical resistance 2
Failure to advance 1
Close, difficult to 1
Malposition of device 1
Folded 1
Folding Issue 1
Buckled material 1
Tip breakage 1
Uncoiled 1
Unraveled material 1
Failure to deliver 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
Positioning Issue 1
Unintended movement 1
No flow 1
Incorrect device or component shipped 1
Total Device Problems 872

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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