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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiovascular procedure kit
Regulation Description Diagnostic intravascular catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEZ
Regulation Number 870.1200
Device Class 2

Device Problems
Leak 139
Out-of-box failure 45
Kinked 41
Disconnection 40
Fluid leak 29
Blockage within device or device component 26
Product quality issue 24
Flare or flash 22
Air leak 19
Fitting problem 17
Crack 14
Foreign material present in device 12
Material opacification 9
Loose or intermittent connection 7
Misassembled 7
Hole in material 5
Break 5
Device damaged prior to use 5
No Information 5
No code available 4
Packaging issue 4
Component missing 4
Shipping damage or problem 4
Loss of or failure to bond 4
Occlusion within device 3
Improper or incorrect procedure or method 3
Increase in pressure 3
Positioning Issue 3
Pressure issue 3
No Known Device Problem 3
Device misassembled during manufacturing or shipping 3
Device Issue 3
Tear, rip or hole in device packaging 3
Cut in material 3
Dent in material 3
Connection issue 3
Incomplete or missing packaging 2
No flow 2
Improper flow or infusion 2
Misassembled by Users 2
Use of Device Issue 2
Defective component 2
Unsealed device packaging 2
Collapse 2
Detachment of device component 2
Difficult to fold or unfold 2
Fracture 1
Inadequate instructions for healthcare professional 1
Misconnection 1
Shock, electrical 1
Electrical issue 1
Uncoiled 1
Material rupture 1
Material separation 1
Other (for use when an appropriate device code cannot be identified) 1
Torn material 1
Incorrect device or component shipped 1
Infusion or flow issue 1
Manufacturing or shipping issue associated with device 1
Material deformation 1
Free or unrestricted flow 1
Device operates differently than expected 1
Device packaging compromised 1
Detachment of device or device component 1
Device markings issue 1
Total Device Problems 566

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

Recalls
Manufacturer Recall Class Date Posted
1 AngioDynamics Inc. II Apr-07-2016
2 Merit Medical Systems, Inc. II Jan-29-2010
3 Navilyst Medical, Inc II Feb-26-2015
4 Navilyst Medical, Inc II Jan-19-2012
5 Terumo Cardiovascular Systems Corp II Aug-31-2016
6 Terumo Cardiovascular Systems Corp II Oct-31-2014
7 Terumo Cardiovascular Systems Corp II Apr-16-2014
8 Terumo Cardiovascular Systems Corp II Mar-28-2008

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