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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, balloon type
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBA
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BYRON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 114
Other (for use when an appropriate device code cannot be identified) 44
Leak 35
Incorrect measurement 13
Hole in material 5
Balloon leak(s) 4
Air leak 3
Material rupture 3
Material separation 3
No code available 3
Low readings 3
Device operates differently than expected 2
Material perforation 2
Balloon burst 2
Inflation issue 2
Bubble(s) 2
Burst 1
Deflation issue 1
Break 1
Unknown (for use when the device problem is not known) 1
Monitor failure 1
Performance 1
Device Issue 1
Meter failure 1
Pressure, insufficient 1
Improper device output 1
Measurements, inaccurate 1
Total Device Problems 251

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

Recalls
Manufacturer Recall Class Date Posted
1 Karl Storz Endoscopy America Inc II Jul-13-2013

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