Device product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548750 (XMD P/N 70-0050-A18)
Z-0977-2016
Product summary
- Event
- Event 73024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39
- Official record key
device-enforcement:Z-0977-2016
Official wording
Reason: 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 contents to leak out of the device in some instances.
Code information: Part Number: M00548750 (XMD P/N 70-0050-A18) Lot Number: 929716
Distribution pattern: Nationwide distribution to MA only.
Derived failure modes
-
Unknown
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 contents to leak out of the device in some instances.