| Device Type ID | 2203 |
| Device Name | Implant, Intragastric For Morbid Obesity |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | LTI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2203 |
| Device | Implant, Intragastric For Morbid Obesity |
| Product Code | LTI |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Fluid Leak | 795 |
Adverse Event Without Identified Device Or Use Problem | 622 |
Device Slipped | 181 |
Free Or Unrestricted Flow | 156 |
Leak / Splash | 86 |
Migration Or Expulsion Of Device | 58 |
Insufficient Information | 57 |
Appropriate Term/Code Not Available | 48 |
Material Erosion | 43 |
No Apparent Adverse Event | 40 |
Patient-Device Incompatibility | 35 |
Device Issue | 24 |
Break | 18 |
Detachment Of Device Or Device Component | 15 |
Migration | 12 |
Inadequacy Of Device Shape And/or Size | 9 |
Inflation Problem | 8 |
Obstruction Of Flow | 8 |
Deflation Problem | 6 |
Fracture | 6 |
Material Deformation | 6 |
Kinked | 5 |
Material Rupture | 4 |
Material Perforation | 4 |
Detachment Of Device Component | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Use Of Device Problem | 4 |
Unintended Movement | 3 |
Expulsion | 3 |
Malposition Of Device | 3 |
Short Fill | 2 |
Improper Flow Or Infusion | 2 |
Patient Device Interaction Problem | 2 |
Material Fragmentation | 2 |
Defective Component | 2 |
Material Integrity Problem | 2 |
Material Discolored | 1 |
Bent | 1 |
Calcified | 1 |
Device Operates Differently Than Expected | 1 |
Gas Leak | 1 |
Material Twisted / Bent | 1 |
Activation, Positioning Or Separation Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Explanted | 1 |
Material Puncture / Hole | 1 |
Retraction Problem | 1 |
Delivered As Unsterile Product | 1 |
Connection Problem | 1 |
Hole In Material | 1 |
Off-Label Use | 1 |
Out-Of-Box Failure | 1 |
Device Or Device Fragments Location Unknown | 1 |
Crack | 1 |
Filling Problem | 1 |
Mechanical Problem | 1 |
Premature Activation | 1 |
Disconnection | 1 |
Positioning Problem | 1 |
| Total Device Problems | 2302 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Apollo Endosurgery Inc | II | Aug-10-2018 |
| 2 | Apollo Endosurgery Inc | II | Sep-30-2014 |
| 3 | Reshape Medical Inc | II | Nov-10-2016 |
| 4 | Reshape Medical Inc | II | Aug-17-2016 |