Z-0954-2016 Class II Terminated
FDA device recall Z-0954-2016 was initiated by Xeridiem Mediem Medical Devices Inc on Dec 23, 2015 and is designated Class II. 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… The recall status is terminated (terminated Oct 25, 2016). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 2, 2016
- Initiation Date
- Dec 23, 2015
- Termination Date
- Oct 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product Description
EndoVive 3s Low Profile Balloon Kits Part Number: M00548280 (XMD P/N 70-0050-712) 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.
Distribution Pattern
Nationwide distribution to MA only.
Code Information
Part Number: M00548280 (XMD P/N 70-0050-712) Lot Number: 929604
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0954-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026