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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
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
UNOMEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Deflation issue 156
Burst 88
Leak 47
Inflation issue 40
Mushroomed 40
Break 38
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
Difficult to remove 9
Blockage within device or device component 8
Device operates differently than expected 8
Dislodged or dislocated 8
Split 7
No Known Device Problem 6
Component(s), broken 6
Detachment of device component 6
Entrapment of device or device component 6
Material separation 6
Hole in material 5
Fluid leak 5
Balloon burst 5
Balloon leak(s) 5
Other (for use when an appropriate device code cannot be identified) 5
Unsealed device packaging 4
Material Protrusion 4
Foreign material present in device 4
Balloon asymmetrical 4
Deflation, cause unknown 4
Kinked 3
Slippage of device or device component 3
Positioning Issue 3
Device packaging compromised 2
Difficult to open or remove packaging material 2
Incorrect device or component shipped 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
Disconnection 2
Crack 2
Failure to expand 2
Torn material 2
Unintended movement 2
No Information 1
No code available 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
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
Item contaminated during manufacturing or shipping 1
Material Distortion 1
Material integrity issue 1
Inadequate user interface 1
Scratched material 1
Output issue 1
Packaging issue 1
Material twisted 1
No flow 1
Total Device Problems 701

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 3 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard, Inc. II Sep-15-2016
2 Coloplast Manufacturing US, LLC II Apr-20-2016
3 Covidien LLC II Mar-21-2016

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