EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoViv...
FDA Recall #Z-1010-2016 — Class II — December 23, 2015
Product Description
EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The EndoVive 3s Low Profile Balloon is indicated for use in adult and pediatric patients who require long-term feeding, are unable to tolerate oral feeding, are at low risk for aspiration or require gastric decompression and/or medication delivery directly into the stomach.
Reason for Recall
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.
Recalling Firm
Xeridiem Mediem Medical Devices Inc — Tucson, AZ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
36
Distribution
Nationwide distribution to MA only.
Code Information
Part Number: M00549590 (XMD P/N 70-0050-F24) Lot Number: 930833
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated