Recall Z-2546-2016 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Medtronic Cardiovascular Surgery-the Heart Valve Division
Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
| Date | Aug 16, 2016 (initiated Aug 3, 2016) |
| Status | Terminated |
| Reason | Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). |
| Root cause | Device Design |
| Action | Firm initiated a recall on 8/3/16 by sending an Urgent Medical Device Correction letter to inform them of the potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers of the recommendations to reduce the rate of vascular trauma events and the procedural uses. The letter informs the customers that the Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with the Dear Doctor communication. Patients with questions can contact Medtronic Cardiovascular Patient Services at 877-526-7890 |
| Quantity | 7,319 units |
| Distribution | Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithu |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.