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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 2017
2 5 4 7 10 1 2 3 6 14 14

Device Problems
Fluid leak 2622
Explanted 2333
Leak 1863
No Known Device Problem 1483
Slippage of device or device component 1042
Device remains implanted 424
Migration of device or device component 242
Patient-device incompatibility 119
Free or unrestricted flow 119
No code available 88
No Information 60
Displacement 60
Inflation issue 52
Deflation issue 47
Not Applicable 45
Break 43
Unknown (for use when the device problem is not known) 41
Device Issue 41
Material erosion 39
Detachment of device or device component 32
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
Detachment of device component 6
Device operates differently than expected 6
Material deformation 6
Torn material 5
Malposition of device 5
Improper or incorrect procedure or method 4
Radiation leak 4
Occlusion within device 4
Extrusion 4
Dislodged or dislocated 3
Unintended movement 3
Infusion or flow issue 3
Difficult to insert 3
Material fragmentation 3
Hole in material 3
Use of Device Issue 3
Device or device fragments location unknown 3
Invalid sensing 2
Retraction problem 2
Material rupture 2
Balloon leak(s) 2
Failure to deploy 2
Improper flow or infusion 2
Positioning Issue 2
Material integrity issue 2
Material twisted 1
Measurement system incompatibility 1
Gas leak 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
Premature deployment 1
Material puncture 1
Delivered as unsterile product 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
Extrusion, impending 1
Folded 1
Aspiration issue 1
Difficult to open or close 1
Connection issue 1
Total Device Problems 11099

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 2 1 0 1 1 0 2 0
Class III 0 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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