EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve d

FDA device recall Z-2264-2015 · posted 2015-08-05 · Terminated

Recall details

Recalling firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

Reason for recall

Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

NPT

Quantity affected

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,

Date initiated

2015-07-15

Date posted

2015-08-05

Date terminated

2016-05-20

Location

Santa Ana, CA