Recall Z-0913-2016— Xeridiem Mediem Medical Devices Inc

Class II FDA medical device recall by Xeridiem Mediem Medical Devices Inc, initiated 2015-12-23, terminated 2016-10-25. FDA's recall record names no specific 510(k) clearance for this event. Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548330 (XMD P/N 70-0050-014) 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: 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

Classification

Class II

Status

Terminated

Initiated

2015-12-23

Terminated

2016-10-25

Firm location

Tucson, AZ, United States

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