| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 126 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 77 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 32 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 32 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 35 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 78 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 91 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 326 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 37 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 38 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 36 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 31 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 33 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 260 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 38 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 186 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 77 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 36 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 39 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 38 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |
| 2015-12-23 | Class II | Device Design | A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delayed manner, when an extension set is disconnected from the Low Profile Balloon device, thus allowing feeding solution or gastric co | 40 | 2016-10-25 |