FDA labels recall of Medtronic’s heart valve loading system Class I

Editor's Note

The Food and Drug Administration on August 5 categorized the recall of 6,912 units of Medtronic Cardiovascular Surgery’s EnVeo R loading system as Class I, the most serious. The loading system is used with the CoreValve Evolut R replacement heart valve.

The recall was issued over concerns about particulate found in some cases, which could cause potential harm such as embolism. 

Class 1 RecallMedtronic EnVeo R Loading System Date Posted August 05, 2015 Recall Status1 Open Recall Number Z-2264-2015 Recall Event ID 71719 Premarket ApprovalPMA Number P130021 Product 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.