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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 144
Burst 52
Inflation issue 40
Leak 39
Mushroomed 39
Break 33
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
Device operates differently than expected 8
Dislodged or dislocated 8
Difficult to remove 8
Blockage within device or device component 8
Split 7
Component(s), broken 6
Entrapment of device or device component 6
Fluid leak 5
Detachment of device component 5
Balloon burst 5
Balloon leak(s) 5
Material separation 5
Hole in material 5
Other (for use when an appropriate device code cannot be identified) 5
No Known Device Problem 5
Material Protrusion 4
Foreign material present in device 4
Unsealed device packaging 4
Deflation, cause unknown 4
Balloon asymmetrical 4
Kinked 3
Slippage of device or device component 3
Disconnection 2
Crack 2
Delivered as unsterile product 2
Improper or incorrect procedure or method 2
Unknown (for use when the device problem is not known) 2
Tear, rip or hole in device packaging 2
Cut in material 2
Device packaging compromised 2
Difficult to open or remove packaging material 2
Incorrect device or component shipped 2
Positioning Issue 2
Failure to expand 2
Torn material 2
Unintended movement 2
No Information 1
No code available 1
Scratched material 1
Output issue 1
Packaging issue 1
Material twisted 1
No flow 1
Item contaminated during manufacturing or shipping 1
Material Distortion 1
Material integrity issue 1
Inadequate user interface 1
Failure to advance 1
Physical resistance 1
Device or device component damaged by another device 1
Folded 1
Patient-device incompatibility 1
Material perforation 1
Defective component 1
Balloon mushroomed 1
Fracture 1
Device expiration issue 1
Twisting 1
Replace 1
Incorrect or inadequate result 1
Material rigid or stiff 1
Knotted 1
Incorrect measurement 1
Nonstandard device or device component 1
Difficult to insert 1
Total Device Problems 634

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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