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.
This recall has been terminated (originally issued August 16, 2016).
- Recall Initiated
- August 3, 2016
- Posted
- August 16, 2016
- Terminated
- March 31, 2017
- Recall Number
- Z-2546-2016
- Quantity
- 7,319 units
- Firm Location
- Santa Ana, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
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, 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.
Lot / Code Info
all lots
Root Cause
Device Design
Action Taken
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 (Monday-Friday, 7:30am-5pm Central Time). Customers with any questions are instructed to contact their Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890. On 8/19/16, firm sent a copy of a customer notification letter that will be sent to their customers to inform them that of the communication letter that was released in August 2016 by Medtronic regarding potential for aortic vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers that FDA classify the recall as a Class II recall and the recall does not require customers to return the product. The recall letter informs the customers that Medtronic has taken further action by updating all customer training materials and the Instructions for Use (IFU).