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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, hemodialysis, implanted, coated
Regulation Description Blood access device and accessories.
Definition Accessing the central vascular system for long term hemodialysis while reducing infection or thrombogenesis.
Product CodeNYU
Regulation Number 876.5540
Device Class 3


Premarket Reviews
ManufacturerDecision
COVIDIEN
  SUBSTANTIALLY EQUIVALENT - KIT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 17
Leak 6
Implant extrusion 2
Growth, will not support 2
Hole in material 1
Failure to Adhere or Bond 1
Component(s), broken 1
No Known Device Problem 1
Migration of device or device component 1
Total Device Problems 32

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 2 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Covidien III Dec-04-2008
2 Covidien LLC II Nov-24-2015
3 Covidien LLC II Jul-01-2015

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