This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU5w  

This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU5w 

Source: Food and Drug Adminstration (FDA): CDRHNew - February 19, 2020 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news