Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure. Find out more: https://go.usa.gov/xy3K7   #MedicalDevicepic.twitter.com/nMub6nAmDt

Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure. Find out more: https://go.usa.gov/xy3K7  #MedicalDevice pic.twitter.com/nMub6nAmDt

Source: Food and Drug Adminstration (FDA): CDRHNew - June 18, 2019 Category: Medical Devices Authors: ( at FDADeviceInfo) Source Type: news