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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 8

Device Problems
Fluid leak 2376
Explanted 2332
Leak 1861
No Known Device Problem 1288
Slippage of device or device component 983
Device remains implanted 424
Migration of device or device component 219
Patient-device incompatibility 119
No code available 67
Displacement 60
Inflation issue 50
Not Applicable 45
Deflation issue 45
Break 43
Unknown (for use when the device problem is not known) 41
Material erosion 38
No Information 30
Detachment of device or device component 28
Kinked 25
Implant, repositioning of 25
Obstruction within device 21
Buckled material 21
Disconnection 21
Free or unrestricted flow 19
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 8
Fracture 6
Device operates differently than expected 6
Torn material 5
Malposition of device 5
Improper or incorrect procedure or method 4
Extrusion 4
Radiation leak 4
Occlusion within device 4
Dislodged or dislocated 3
Infusion or flow issue 3
Difficult to insert 3
Detachment of device component 3
Material fragmentation 3
Hole in material 3
Failure to deploy 2
Material deformation 2
Positioning Issue 2
Balloon leak(s) 2
Device or device fragments location unknown 2
Retraction problem 2
Invalid sensing 2
Delivered as unsterile product 1
Source, leak(s) from 1
Use of Device Issue 1
Difficult to open or close 1
Balloon rupture 1
Difficult to flush 1
Material puncture 1
Material twisted 1
Measurement system incompatibility 1
Bent 1
Calcified 1
Tube(s), defective 1
Material integrity issue 1
Failure to Adhere or Bond 1
Material perforation 1
Implant, removal of 1
Improper flow or infusion 1
Crack 1
Filling problem 1
Mechanical issue 1
Difficult to position 1
Source, detachment from 1
Tubing, incorrect placement of 1
Implant extrusion 1
Component falling 1
Extrusion, impending 1
Material rupture 1
Rupture, cause unknown 1
Unintended movement 1
Aspiration issue 1
Blockage within device or device component 1
Difficult to fold or unfold 1
Sticking 1
Port leak(s) 1
Unsealed device packaging 1
Air leak 1
Device clogged 1
Visibility/palpability 1
Folded 1
Out-of-box failure 1
Total Device Problems 10367

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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