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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, intragastric for morbid obesity
Product CodeLTI
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
2 5 4 7 10 1 2 3 6 10

Device Problems
Fluid leak 2405
Explanted 2332
Leak 1861
No Known Device Problem 1303
Slippage of device or device component 992
Device remains implanted 424
Migration of device or device component 221
Patient-device incompatibility 119
No code available 79
Displacement 60
Inflation issue 50
Deflation issue 46
Not Applicable 45
Break 43
Unknown (for use when the device problem is not known) 41
Material erosion 38
No Information 31
Detachment of device or device component 30
Implant, repositioning of 25
Kinked 25
Free or unrestricted flow 23
Disconnection 21
Obstruction within device 21
Buckled material 21
Device Issue 18
Other (for use when an appropriate device code cannot be identified) 15
Disengaged 13
Reflux within device 11
Device, removal of (non-implant) 11
Size incorrect for patient 9
Device operates differently than expected 6
Fracture 6
Detachment of device component 5
Malposition of device 5
Torn material 5
Extrusion 4
Improper or incorrect procedure or method 4
Radiation leak 4
Occlusion within device 4
Difficult to insert 3
Material fragmentation 3
Hole in material 3
Dislodged or dislocated 3
Infusion or flow issue 3
Material deformation 2
Positioning Issue 2
Device or device fragments location unknown 2
Invalid sensing 2
Retraction problem 2
Balloon leak(s) 2
Failure to deploy 2
Filling problem 1
Bent 1
Blockage within device or device component 1
Air leak 1
Failure to Adhere or Bond 1
Balloon rupture 1
Component falling 1
Crack 1
Calcified 1
Device clogged 1
Difficult to flush 1
Difficult to fold or unfold 1
Mechanical issue 1
Unsealed device packaging 1
Port leak(s) 1
Difficult to position 1
Material puncture 1
Delivered as unsterile product 1
Material rupture 1
Rupture, cause unknown 1
Source, detachment from 1
Source, leak(s) from 1
Sticking 1
Tubing, incorrect placement of 1
Use of Device Issue 1
Tube(s), defective 1
Out-of-box failure 1
Implant, removal of 1
Implant extrusion 1
Visibility/palpability 1
Material perforation 1
Difficult to open or close 1
Extrusion, impending 1
Folded 1
Aspiration issue 1
Improper flow or infusion 1
Material integrity issue 1
Material twisted 1
Measurement system incompatibility 1
Unintended movement 1
Total Device Problems 10445

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

Recalls
Manufacturer Recall Class Date Posted
1 Allergan II May-02-2011
2 Allergan II Nov-18-2010
3 Apollo Endosurgery Inc II Sep-30-2014
4 Ethicon Endo-Surgery Inc II Nov-05-2013
5 Ethicon Endo-Surgery Inc II Nov-02-2010

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