Recall Z-0915-2016— Xeridiem Mediem Medical Devices Inc

Name: FDA recall Z-0915-2016
Creator: U.S. Food and Drug Administration
Published: 2015-12-23

Class II · Terminated

Class II FDA medical device recall by Xeridiem Mediem Medical Devices Inc, initiated 2015-12-23, terminated 2016-10-25. It names one FDA 510(k) clearance: K142297. Product: EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) 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

510(k) clearances named in this recall

1 on FDA's record

K142297 — Endo Vive 3S Low Profile Balloon Kit, Endo Vive 3S Bolus Extension Sets, Endo Vive 3S Continuous Extension Sets, Endo Vive 3S Medication Extension SetXeridiem (Formerly Mri)·cleared 2015-01-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.