Recall Z-2264-2015 ยท NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Medtronic Cardiovascular Surgery-the Heart Valve Division
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
| Date | Aug 5, 2015 (initiated Jul 15, 2015) |
| Status | Terminated |
| Reason | Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. |
| Root cause | Process control |
| Action | An Urgent Medical Device Recall Letter dated July 2015 will be be sent to customers who purchased the EnVeo R Loading System because Medtronic has received 8 reports related to this issue out of 7347 potentially affected units. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer confirmation certificate and to email RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality. |
| Quantity | 6,912 units total (540 units in US) |
| Distribution | Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.