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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 2
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 4

Device Problems
Deflation issue 148
Burst 78
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
Fluid leak 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
Unsealed device packaging 4
Material Protrusion 4
Foreign material present in device 4
Deflation, cause unknown 4
Balloon asymmetrical 4
Kinked 3
Slippage of device or device component 3
Disconnection 2
Crack 2
Device packaging compromised 2
Difficult to open or remove packaging material 2
Incorrect device or component shipped 2
Positioning Issue 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
Failure to expand 2
Torn material 2
Unintended movement 2
No Information 1
No code available 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
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
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 681

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 3
Class III 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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