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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transcatheter septal occluder
Definition Approved PMA: P000039
Product CodeMLV
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 9 11 6 13 9 5 7 5 16

Device Problems
Migration of device or device component 52
Explanted 32
No Information 23
Difficult to remove 13
Replace 13
Device, removal of (non-implant) 11
Malposition of device 10
Size incorrect for patient 10
Device remains implanted 7
Sticking 6
Dislodged 6
Implant, removal of 5
Positioning Issue 5
Dislodged or dislocated 5
Material erosion 4
Entrapment of device or device component 3
Break 3
Detachment of device component 3
Retraction problem 3
Material deformation 3
Failure to advance 3
Deployment issue 2
Extrusion 2
No Known Device Problem 2
Material separation 2
Difficult to position 2
Slippage of device or device component 2
Unstable 2
Use of Device Issue 2
Failure to deploy 2
Fracture 2
Difficult to insert 1
Kinked 1
Loose 1
Mechanical issue 1
Foreign material 1
Mislocation 1
Component(s), worn 1
Collapse 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Stretched 1
Tip breakage 1
Premature deployment 1
Device, or device fragments remain in patient 1
No code available 1
Material integrity issue 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Buckled material 1
Physical resistance 1
Obstruction within device 1
Total Device Problems 261

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

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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