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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, nephrostomy, general & plastic surgery
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBO
Regulation Number 878.4200
Device Class 1

Device Problems
Material separation 49
Other (for use when an appropriate device code cannot be identified) 20
Break 12
Leak 9
Difficult to remove 7
Fluid leak 4
Component(s), broken 3
Detachment of device component 3
Unknown (for use when the device problem is not known) 3
Fitting problem 3
Suture line separation 2
Tip breakage 2
No Known Device Problem 2
Fracture 2
Kinked 2
Occlusion within device 2
Migration of device or device component 1
Material rupture 1
Sterility 1
Hole in material 1
Burst 1
Crack 1
Disconnection 1
No code available 1
Wire(s), breakage of 1
Device Issue 1
Tear, rip or hole in device packaging 1
Cut in material 1
Device, removal of (non-implant) 1
Malposition of device 1
Aspiration issue 1
Detachment of device or device component 1
Device packaging compromised 1
Difficult to advance 1
Dislodged or dislocated 1
Expulsion 1
Total Device Problems 145

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 0 1 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 May-21-2009

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