Device Recall EndoVive 3s Low Profile Balloon Kits 의 리콜

Recall

73024

Class 2

Z-0930-2016

2015-12-23

Terminated

United States

2016-10-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142794

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.

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.