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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, catheter, ureteral
Regulation Description Ureteral dilator.
Product CodeEZN
Regulation Number 876.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burst 64
Inflation issue 51
Leak 44
Balloon burst 42
Kinked 32
Balloon rupture 26
Balloon leak(s) 25
Hole in material 16
Deflation issue 12
Device Issue 12
Balloon pinhole 10
Bent 10
Tears, rips, holes in device, device material 9
Torn material 6
Failure to advance 5
Defective item 5
Material perforation 5
Material rupture 5
Other (for use when an appropriate device code cannot be identified) 5
Break 5
Material fragmentation 4
Difficult to remove 4
Device damaged prior to use 4
No Known Device Problem 3
Fitting problem 3
Material separation 3
Tip breakage 2
Unknown (for use when the device problem is not known) 2
Unsealed device packaging 2
Device operates differently than expected 2
Device packaging compromised 2
Foreign material present in device 2
Tear, rip or hole in device packaging 2
Pressure, insufficient 1
Defective component 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Material deformation 1
Difficult to advance 1
Difficult to position 1
Decrease in pressure 1
Material puncture 1
Unable to obtain readings 1
Reuse 1
Source, detachment from 1
Detachment of device component 1
Device abrasion from instrument or another object 1
Mislabeled 1
Delivered as unsterile product 1
Displacement 1
False reading from device non-compliance 1
Foreign material 1
Total Device Problems 443

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 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-30-2008

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