• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
Air leak 22
Flare or flash 22
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
Tear, rip or hole in device packaging 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
Cut in material 3
Dent in material 3
Connection issue 3
Device misassembled during manufacturing or shipping 3
Device Issue 3
Positioning Issue 3
Pressure issue 3
No Known Device Problem 3
Misassembled by Users 2
No flow 2
Improper flow or infusion 2
Incomplete or missing packaging 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 2
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
Device operates differently than expected 1
Device packaging compromised 1
Detachment of device or device component 1
Device markings issue 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
Torn material 1
Total Device Problems 571

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

-
-