Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Medtronic Cardiovascular Surgery-the Heart Valve Division
4 recalls • • Categories: Implants & Prosthetics, Infusion Pumps, Other Medical Devices
Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.
Medtronic has decided to discontinue production and distribution of this low-volume product.
Class I - Dangerous
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.