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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stabilizer,heart
Regulation Description Cardiovascular surgical instruments.
Product CodeMWS
Regulation Number 870.4500
Device Class 1


Premarket Reviews
ManufacturerDecision
CARDIO THORACIC SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 60
Detachment of device component 19
Mechanical issue 13
Fracture 4
Other (for use when an appropriate device code cannot be identified) 4
Component(s), broken 3
Replace 3
Material rigid or stiff 3
Use of Device Issue 3
Suction issue 3
No Information 3
Performance 2
Pressure issue 2
Size incorrect for patient 2
Unstable 2
Decrease in suction 2
Material frayed 1
Device abrasion from instrument or another object 1
Unintended system motion 1
Material perforation 1
Component missing 1
Connection issue 1
Device operates differently than expected 1
Device packaging compromised 1
Mechanics altered 1
Positioning Issue 1
Inadequate service 1
Total Device Problems 139

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

Recalls
Manufacturer Recall Class Date Posted
1 Guidant Cardiac Surgery II Mar-16-2007
2 Maquet Cardiovascular, LLC II Oct-24-2014
3 Maquet Cardiovascular, LLC II Feb-06-2012

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