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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 13

Device Problems
Fluid leak 2479
Explanted 2332
Leak 1862
No Known Device Problem 1351
Slippage of device or device component 1012
Device remains implanted 424
Migration of device or device component 229
Patient-device incompatibility 119
No code available 84
Displacement 60
Inflation issue 51
Free or unrestricted flow 51
Deflation issue 46
Not Applicable 45
Break 43
Unknown (for use when the device problem is not known) 41
Device Issue 39
Material erosion 38
No Information 38
Detachment of device or device component 31
Kinked 26
Implant, repositioning of 25
Obstruction within device 21
Buckled material 21
Disconnection 21
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
Fracture 7
Device operates differently than expected 6
Malposition of device 5
Detachment of device component 5
Torn material 5
Extrusion 4
Radiation leak 4
Occlusion within device 4
Improper or incorrect procedure or method 4
Dislodged or dislocated 3
Difficult to insert 3
Material fragmentation 3
Hole in material 3
Infusion or flow issue 3
Material deformation 2
Material integrity issue 2
Improper flow or infusion 2
Positioning Issue 2
Unintended movement 2
Balloon leak(s) 2
Failure to deploy 2
Device or device fragments location unknown 2
Use of Device Issue 2
Invalid sensing 2
Retraction problem 2
Material rupture 1
Rupture, cause unknown 1
Source, detachment from 1
Source, leak(s) from 1
Sticking 1
Tubing, incorrect placement of 1
Tube(s), defective 1
Out-of-box failure 1
Implant, removal of 1
Implant extrusion 1
Visibility/palpability 1
Material perforation 1
Defective component 1
Difficult to open or close 1
Extrusion, impending 1
Folded 1
Aspiration issue 1
Material discolored 1
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 twisted 1
Measurement system incompatibility 1
Total Device Problems 10667

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 2
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
6 Reshape Medical Inc II Nov-10-2016
7 Reshape Medical Inc II Aug-17-2016

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