Class I medical Device Archives - Public Safety & Vigilance

Medical Device Class I recall: Langston® Dual Lumen Catheters

May 2, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesClass I medical Device, Class I medical device recall, Dual Lumen Catheters, Langston, Most serious type of medical device recall

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

Apr 9, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, Medical Device Updates, USFDA-United States of AmericaBoston Scientific Corporation, Class I medical Device, IMAGER II 5F Angiographic Catheters, Most serious type of medical device recall, Recall of Class I medical Device, USFDA alerts, USFDA Medical Device Recall

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

Apr 7, 2020Public Safety & VigilanceMedical Device, Medical Device Recall, Medical Device UpdatesClass I medical Device, Class I medical device recall, LeMaitre Over the Wire Embolectomy Catheter, Medical Device Recall, Most serious type of medical device recall, USFDA alerts

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…

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.

Public Safety & Vigilance

A common platform for safety alerts, news and other important updates for Medicinal Products and Medical Devices from health regulatory authorities across the globe.

Tag: Class I medical Device

Medical Device Class I recall: Langston® Dual Lumen Catheters

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

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