Recall Z-2546-2016— Medtronic Cardiovascular Surgery-the Heart Valve Division

Name: FDA recall Z-2546-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-03

Class II · Terminated

Class II FDA medical device recall by Medtronic Cardiovascular Surgery-the Heart Valve Division, initiated 2016-08-03, terminated 2017-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS)..

Recalling firm: Medtronic Cardiovascular Surgery-the Heart Valve Division
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Terminated: 2017-03-31
Firm location: Santa Ana, CA, United States

Product description

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.

Reason for recall

Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).

Data sourced from openFDA. This site is unofficial and independent of the FDA.