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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 11

Device Problems
Fluid leak 2431
Explanted 2332
Leak 1861
No Known Device Problem 1319
Slippage of device or device component 1001
Device remains implanted 424
Migration of device or device component 223
Patient-device incompatibility 119
No code available 83
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
Device Issue 37
Free or unrestricted flow 33
No Information 32
Detachment of device or device component 31
Implant, repositioning of 25
Kinked 25
Disconnection 21
Buckled material 21
Obstruction within device 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
Radiation leak 4
Occlusion within device 4
Extrusion 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
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
Use of Device Issue 1
Tube(s), defective 1
Out-of-box failure 1
Implant, removal of 1
Implant extrusion 1
Material perforation 1
Defective component 1
Extrusion, impending 1
Folded 1
Visibility/palpability 1
Difficult to open or close 1
Aspiration issue 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 10538

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 1
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 Aug-17-2016

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