Xeridiem Mediem Medical Devices Inc: Medical Device Recall in 2016 - (Recall #: Z-0945-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

EndoVive 3s Low Profile Balloon Kits Part Number: M005489350 (XMD P/N 70-0050-522) 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.

Product Classification:

Class II

Date Initiated: December 23, 2015

Date Posted: March 2, 2016

Recall Number: Z-0945-2016

Event ID: 73024

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.

Status: Terminated

Product Quantity: 36

Code Information:

Part Number: M005489350 (XMD P/N 70-0050-522) Lot Number: 930142

Distribution Pattern:

Nationwide distribution to MA only.

Voluntary or Mandated:

Voluntary: Firm initiated