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.
Enforcement
- Recall Number
- Z-2546-2016
- Event ID
- 74796
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Cardiovascular Surgery-the Heart Valve Division
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 24, 2016
- Initiation Date
- August 3, 2016
- Classification Date
- August 16, 2016
- Termination Date
- March 31, 2017
- Address
- 1851 E Deere Ave, N/A, Santa Ana, CA, 92705-5720, United States
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.
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
all lots
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, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
7,319 units