—#142987

Product

EndoVive 3s Low Profile Balloon Kits Part Number: M00548960 (XMD P/N 70-0050-F20) 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.

FDA product code: PIF — Gastrointestinal Tubes With Enteral Specific Connectors
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K142297
Affected lot / code info: Part Number: M00548960 (XMD P/N 70-0050-F20) Lot Number: 930136

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

Xeridiem sent a customer notification letter dated December 23, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customer was provided the following instructions: 1. Segregate all devices from the above table that in Boston Scientific Corporation's inventory and restrict them from being distributed to end users. 2. Determine the list of end users who have received devices from the above list, notify them of the quality issue, and have these devices returned to Boston Scientific Corporation. Provide Xeridiem Medical Devices with this list of end users. For any questions the customers is instructed to contact the firm. For questions regarding this recall call 520-882-7794.

Recalling firm

Firm: Xeridiem Mediem Medical Devices Inc
Address: 4700 S Overland Dr, Tucson, Arizona 85714-3430

Distribution

Distribution pattern: Nationwide distribution to MA only.

Timeline

Recall initiated: 2015-12-23
Terminated: 2016-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #142987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.