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Xeridiem Mediem Medical Devices Inc recalls EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) The EndoVive 3s Low Profile Balloo
Recalled March 2, 2016 · FDA recall Z-0958-2016 · Xeridiem Mediem Medical Devices
Hazard
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. · FDA Class II
Units
37
Sold at
Nationwide distribution to MA only.
Description
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.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548880 (XMD P/N 70-0050-720) 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.
Manufacturer(s)
Xeridiem Mediem Medical Devices Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →