Recall of Class I medical Device Archives - Public Safety & Vigilance

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

Jun 17, 2020Public Safety & VigilanceGlobal Safety Alerts, Medical Device, Medical Device Recall, US-FDA, USFDA-United States of AmericaOvation iX Abdominal Stent Graft Systems, Recall of Class I medical Device, USFDA Medical Device Recall

On 16-Jun-2020, US-FDA released a recall alert for class I medical Device– Ovation 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

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…

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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: Recall of Class I medical Device

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

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