EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 — Class II medical device recall Z-0978-2016
Terminated recall by Xeridiem Mediem Medical Devices Inc, reported 2016-03-02, distributed nationwide. A feeding (reflux) valve leakage issue. The feeding valve appears to close inconsistently, or close in a delay
| Recall number | Z-0978-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Xeridiem Mediem Medical Devices Inc, Tucson, AZ, United States |
| Recall initiated | 2015-12-23 |
| Classified | 2016-02-25 |
| Reported by FDA | 2016-03-02 |
| Terminated | 2016-10-25 |
| Distributed | Nationwide (US) |
| Quantity | 40 |
| Reason classes | packaging |
| Lot numbers | 930131 |
| Model numbers | M00548910 |
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548910 (XMD P/N 70-0050-A20) 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0978-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.