Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

Recall of Class I Medical Device- Ovation iX Abdominal Stent Graft Systems

On 16-Jun-2020, US-FDA released a recall alert for class I medical DeviceРOvation iX Abdominal Stent Graft Systems due to the risks of polymer leaks during implantation Device Use: This device is used in endovascular treatment for patients with an abdominal aortic or aortoiliac aneurysms (AAA). Aortic Aneurysm is a condition which occurs when the aorta

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

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