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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Product CodeMUQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
3 1 2 1 0 1 1 0 1 5

Device Problems
No Known Device Problem 52
No Information 7
No code available 7
Failure to Adhere or Bond 3
Device operates differently than expected 2
Device clogged 1
Contamination during use 1
Material fragmentation 1
Occlusion within device 1
Patient-device incompatibility 1
Total Device Problems 76

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

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II May-30-2014

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