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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cannula, arterial, cardiopulmonary bypass (cpb), embolism protection
Regulation Description Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Product CodeNCP
Regulation Number 870.4210
Device Class 2

Device Problems
Balloon rupture 76
Balloon burst 17
Device damaged prior to use 17
Balloon leak(s) 15
Leak 11
Collapse 9
Foreign material 5
Balloon asymmetrical 4
Material separation 4
Detachment of device component 3
Component(s), broken 2
Failure to service 2
Restricted flowrate 2
Material rupture 2
Slippage of device or device component 1
Valve(s), defective 1
Stopcock valve, failure of 1
Residue after decontamination 1
Dissatisfaction 1
Balloon pinhole 1
Break 1
Device clogged 1
Dislodged 1
Kinked 1
Loose or intermittent connection 1
Markings, none 1
Difficult to position 1
Total Device Problems 182

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 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Inc. II Aug-15-2012

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