Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD Recalled by Xeridiem Mediem Medical Devices Inc Due to A feeding (reflux) valve leakage issue. The feeding...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Xeridiem Mediem Medical Devices Inc directly.
Affected Products
EndoVive 3s Low Profile Balloon Kits Part Number: M00548560 (XMD P/N 70-0050-716) 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.
Quantity: 115
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Xeridiem Mediem Medical Devices Inc
Xeridiem Mediem Medical Devices Inc has 105 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report