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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, urological
Regulation Description Urological catheter and accessories.
Product CodeKOD
Regulation Number 876.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ABCO DEALERS, INC.
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BEIERSDORF
  SUBSTANTIALLY EQUIVALENT 2
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 7
COLOPLAST MANUFACTURING US LLC
  SUBSTANTIALLY EQUIVALENT 1
CONVATEC LIMITED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 7
ENDOCARE, INC.
  SUBSTANTIALLY EQUIVALENT 2
GO MEDICAL INDUSTRIES PTY. LTD.
  SUBSTANTIALLY EQUIVALENT 1
HOLLISTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
INAMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
KENDALL
  SUBSTANTIALLY EQUIVALENT 12
LEVEL 1
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
PLUROMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
RESPIRATORY SUPPORT PRODUCTS, INC. (RSP)
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SHERIDAN CATHETER CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
TYCO HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 2
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
WELCON, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Deflation issue 129
Break 65
Burst 49
Defective item 38
Failure to disconnect 35
Other (for use when an appropriate device code cannot be identified) 35
Balloon burst 33
Inflation issue 30
Failure to advance 28
Leak 25
No Information 24
No Known Device Problem 23
Detachment of device component 21
Peeled 20
Foreign material present in device 20
Device operates differently than expected 16
Difficult to remove 16
Material rigid or stiff 16
Bent 15
Patient-device incompatibility 14
Difficult to open or remove packaging material 14
Material deformation 13
Material integrity issue 13
Difficult to insert 13
Premature deployment 11
Failure to deploy 10
Difficult to deploy 9
Unsealed device packaging 9
Improper or incorrect procedure or method 9
Mushroomed 9
Device damaged prior to use 9
Failure to separate 8
Device, or device fragments remain in patient 8
Material separation 7
Material rupture 6
Delivered as unsterile product 6
Material fragmentation 6
Device Issue 6
Close, difficult to 6
Packaging issue 6
No code available 5
Folded 5
Detachment of device or device component 5
Tear, rip or hole in device packaging 5
Deflation, cause unknown 5
Contamination during use 5
Occlusion within device 5
Misapplication 5
Product quality issue 5
Kinked 5
Mislabeled 4
Sticking 4
Tip breakage 4
Balloon rupture 4
Foreign material 4
Unintended movement 4
Difficult to open or close 4
Difficult to advance 3
Item contaminated during manufacturing or shipping 3
Defective component 3
Failure to deliver 3
Deployment issue 3
Tears, rips, holes in device, device material 3
Device, removal of (non-implant) 3
Fracture 3
Device expiration issue 3
Flaked 3
Material frayed 3
Device maintenance issue 3
Component(s), broken 3
Blockage within device or device component 3
Unknown (for use when the device problem is not known) 3
Source, detachment from 3
Slippage of device or device component 2
Replace 2
Material perforation 2
Inadequate instructions for healthcare professional 2
Inability to irrigate 2
Disassembly 2
Material discolored 2
Melted 2
Migration of device or device component 2
Malposition of device 2
Device packaging compromised 2
Device disinfection or sterilization issue 2
Device markings issue 2
Buckled material 2
Malfunction 2
Split 2
Cut in material 2
Structural problem 2
Dislodged or dislocated 2
Not Applicable 2
Torn material 2
Manufacturing or shipping issue associated with device 1
Incorrect device or component shipped 1
Scratched material 1
No flow 1
Material Protrusion 1
Mechanical jam 1
Total Device Problems 1004

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 1 1 3 3 0 3 2 1 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-11-2012
2 Boston Scientific Corporation II Jan-21-2010
3 C.R. Bard, Inc. II Sep-03-2015
4 C.R. Bard, Inc. II Aug-14-2015
5 C.R. Bard, Inc., Urological Division II Oct-04-2012
6 Convatec Inc. II Mar-20-2014
7 Nurse Assist, Inc II Jan-11-2012
8 Nurse Assist, Inc II May-25-2011
9 Rochester Medical Corp II Mar-16-2009
10 Teleflex Medical II Dec-16-2016
11 Teleflex Medical II Sep-18-2014
12 Teleflex Medical II Jun-09-2014
13 Teleflex Medical II Aug-03-2011
14 Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN II Jan-25-2011

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