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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 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 7
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 9
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 145
Difficult to remove 95
Material separation 86
Calcified 86
Tears, rips, holes in device, device material 38
Knotted 34
Migration of device or device component 34
Torn material 28
No Known Device Problem 27
Kinked 25
Component(s), broken 25
Device damaged prior to use 19
Detachment of device component 17
Occlusion within device 16
Detachment of device or device component 15
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
Fracture 8
Blockage within device or device component 7
Tear, rip or hole in device packaging 7
Out-of-box failure 7
Cut in material 7
Device operates differently than expected 7
Device packaging compromised 7
Implant, removal of 6
Difficult to position 6
No code available 6
Defective item 5
No Information 5
Unsealed device packaging 5
Elective removal 5
Stretched 5
Split 5
Patient-device incompatibility 4
Unknown (for use when the device problem is not known) 4
Defective component 4
Malfunction 4
Device Issue 4
Replace 4
Difficult to insert 4
Material fragmentation 3
Crack 3
Obstruction within device 3
Material perforation 3
Foreign material present in device 3
Material deformation 2
Packaging issue 2
Suture line separation 2
Device markings issue 2
Difficult to advance 2
Dislodged or dislocated 2
Physical resistance 2
Failure to advance 2
Disconnection 2
Contamination during use 2
Material frayed 2
Entrapment of device or device component 2
Source, detachment from 2
Peeled 2
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
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
Positioning Issue 1
Unintended movement 1
No flow 1
Incorrect device or component shipped 1
Total Device Problems 913

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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