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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, retention type, balloon
Regulation Description Urological catheter and accessories.
Product CodeEZL
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 10
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ENTRACARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
HOSPIRA INC.
  SUBSTANTIALLY EQUIVALENT 4
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 3
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMARY CARE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
RUSCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Deflation issue 135
Burst 45
Inflation issue 40
Mushroomed 39
Leak 37
Break 30
Material deformation 26
Defective item 21
Occlusion within device 18
Bent 17
Manufacturing or shipping issue associated with device 11
Material rupture 10
Device markings issue 10
Blockage within device or device component 8
Difficult to remove 8
Device operates differently than expected 8
Dislodged or dislocated 8
Split 7
Component(s), broken 6
Entrapment of device or device component 6
Balloon leak(s) 5
Fluid leak 5
Other (for use when an appropriate device code cannot be identified) 5
Detachment of device component 5
Hole in material 5
Material separation 5
Balloon burst 5
No Known Device Problem 5
Unsealed device packaging 4
Foreign material present in device 4
Balloon asymmetrical 4
Deflation, cause unknown 4
Kinked 3
Slippage of device or device component 3
Cut in material 2
Difficult to open or remove packaging material 2
Crack 2
Torn material 2
Positioning Issue 2
Disconnection 2
Incorrect device or component shipped 2
Unintended movement 2
Device packaging compromised 2
Failure to expand 2
Delivered as unsterile product 2
Unknown (for use when the device problem is not known) 2
Improper or incorrect procedure or method 2
Tear, rip or hole in device packaging 2
Failure to advance 1
Material integrity issue 1
Defective component 1
Material twisted 1
Fracture 1
Physical resistance 1
Patient-device incompatibility 1
Incorrect measurement 1
No code available 1
No flow 1
Replace 1
Twisting 1
Balloon mushroomed 1
Material Protrusion 1
Material rigid or stiff 1
Folded 1
Device or device component damaged by another device 1
Knotted 1
Item contaminated during manufacturing or shipping 1
Difficult to insert 1
Material Distortion 1
Scratched material 1
No Information 1
Device expiration issue 1
Nonstandard device or device component 1
Incorrect or inadequate result 1
Inadequate user interface 1
Output issue 1
Packaging issue 1
Material perforation 1
Total Device Problems 610

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 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Coloplast Manufacturing US, LLC II Apr-20-2016
2 Covidien LLC II Mar-21-2016

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