Product Recall
FDA labels Cordis’ recall of angiographic catheters as class I
The FDA has identified Cordis’ recall of its angiographic catheter with radiopaque marker bands as Class I, the most serious type of recall.
FDA designates recall of two venous stent systems as class I
The FDA has identified Boston Scientific’s recall of two venous stent systems as class I, the most serious type of recall, due to risk for stent migration that may cause injury or death.
FDA designates recall of two bradycardia pacemakers as Class I
The FDA has identified Abbott’s recall of two scalable bradycardia platform pacemakers as Class I, the most serious type of recall.
FDA identifies recall of Medtronic blood pump as Class I
The FDA has identified the recall of Medtronic Perfusion Systems’ extracorporeal blood pumping console as a Class I, the most serious type of recall.
Recall of ventricular assist device implant kit designated Class I
The FDA has identified Medtronic’s recall of its ventricular assist device implant kit as Class I recall, the most serious type, due to risk for serious injuries or death.
Medtronic recalls thoracic stent graft due to risk for stent fractures, death
Medtronic announced a global voluntary recall of unused thoracic stent graft systems and notified physicians to immediately cease use until further notice.
Recent FDA updates: Device recalls, expanded indications for HF therapies and more
Healio and Cardiology Today have aggregated the latest news from the FDA.
FDA designates recalls of two vascular catheters as Class I
The FDA has classified Cook Medical’s recall of two catheters used in vascular procedures as Class I, the most serious type.
Clot removal devices for patients with stroke urgently recalled
The FDA announced that in response to its request, Penumbra has issued an urgent recall of reperfusion catheters for clot removal in patients with stroke due to risk for unexpected death or serious injury.
Boston Scientific recalls all Lotus Edge TAVR systems, halts research, manufacturing
Boston Scientific announced it has initiated a global voluntary recall of all unused inventory of its transcatheter aortic valve replacement system due to complexities linked to the product delivery system, according to a press release.