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U.S. Department of Health and Human Services

Class 2 Device Recall EndoVive 3s Low Profile Balloon Kits

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  Class 2 Device Recall EndoVive 3s Low Profile Balloon Kits see related information
Date Initiated by Firm December 23, 2015
Create Date February 26, 2016
Recall Status1 Terminated 3 on October 25, 2016
Recall Number Z-0941-2016
Recall Event ID 73024
510(K)Number K142297  
Product Classification Gastrointestinal Tubes with Enteral Specific Connectors - Product Code PIF
Product EndoVive 3s Low Profile Balloon Kits
Part Number:
M00548380
(XMD P/N 70-0050-514)
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.
Code Information Part Number: M00548380 (XMD P/N 70-0050-514)  Lot Number: 911109 915409 915909 920609 928910 930840
Recalling Firm/
Manufacturer
Xeridiem Mediem Medical Devices Inc
4700 S Overland Dr
Tucson AZ 85714-3430
For Additional Information Contact
520-882-7794
Manufacturer 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.
FDA Determined
Cause 2
Device Design
Action 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.
Quantity in Commerce 205
Distribution Nationwide distribution to MA only.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PIF and Original Applicant = XERIDIEM (FORMERLY MRI)
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