Medical Device Class I recall: Langston® Dual Lumen Catheters

United States FDA announced that Vascular Solutions, Inc. is recalling Langston Dual Lumen Catheter, (a class I medical device) due to risk of separation during use During angiographic studies (Medical imaging tests), this Langston Dual Lumen Catheter is utilized for the rapid delivery of contrast agents (dye materials) into the patient blood vessels. This will

Recall of a Class I Medical Device: IMAGER II 5F Angiographic Catheters

A serious type of recall for medical device class I has announced by FDA for the Boston Scientific Corporation IMAGER II 5F Angiographic Catheters. This class I device is used to provide a pathway to deliver contrast agents to blood vessels including carotid arteries during angiography. During the patient procedure preparation, potential for the catheter

Recall of a Class I Medical Device: A most serious type recall

The announcement of recall and withdrawal of medicinal products and medical devices of class II and class III from market is considered usual. The recall scenario of a class I medical device due to serious injury to patient’s health is very rare and requires quite attention. Class I medical devices are “considered safe” which does not

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