Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 7
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 81
Material separation 48
Tears, rips, holes in device, device material 38
Calcified 37
Difficult to remove 28
Torn material 24
Component(s), broken 20
Migration of device or device component 17
Detachment of device component 14
Device damaged prior to use 13
Kinked 10
Other (for use when an appropriate device code cannot be identified) 9
Device, or device fragments remain in patient 8
Cut in material 7
Device, removal of (non-implant) 7
Detachment of device or device component 7
Implant, removal of 6
Tear, rip or hole in device packaging 6
Blockage within device or device component 6
Knotted 6
Elective removal 5
Unsealed device packaging 5
Difficult to position 5
No Information 5
Device Issue 4
Defective item 4
No Known Device Problem 4
Out-of-box failure 4
Replace 4
Unknown (for use when the device problem is not known) 4
Difficult to insert 4
Crack 3
Material perforation 3
Occlusion within device 3
Defective component 3
Obstruction within device 3
Split 3
Physical resistance 2
Patient-device incompatibility 2
Device markings issue 2
Source, detachment from 2
Material fragmentation 2
Hole in material 1
Insulation degradation 1
Mislabeled 1
Entrapment of device or device component 1
Device expiration issue 1
Explanted 1
Fracture 1
Sterility 1
Stretched 1
Suture line separation 1
Unraveled material 1
Peeled 1
Device Difficult to Setup or Prepare 1
Difficult to advance 1
Foreign material present in device 1
Incorrect device or component shipped 1
Material deformation 1
Failure to advance 1
Close, difficult to 1
Malposition of device 1
Folded 1
Folding Issue 1
Failure to deliver 1
Total Device Problems 491

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 1 3 0 1 0 0
Class III 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 Jan-05-2011
4 Vance Products Incorporated II Feb-10-2009
5 Vance Products Incorporated II Jan-23-2009

-
-