Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock

FDA device recall Z-2623-2014 · posted 2014-09-11 · Terminated

Recall details

Recalling firm

Medtronic Cardiovascular Surgery-the Heart Valve Division

Reason for recall

Medtronic has decided to discontinue production and distribution of this low-volume product.

Action taken

An Urgent Medical Device Recall letter, dated August, 2014, was sent to customers on 8/15/14 for specific serial numbers of Hancock Apical Left Ventricle Connector, model H174Axx, devices. This recall is the result of a decision by Medtronic to discontinue sales of this low volume product, in lieu of fulfilling new regulatory requirements to maintain its distribution in the United States. Customers are instructed to quarantine and return all listed product in their inventory to Medtronic and contact customer service at (800) 854-3570. Customers are instructed to complete the attached customer confirmation certificate and e-mail it to RS.CFQFCA@Medtronic.com or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.

Root cause

Component design/selection

Status

Terminated

Product code

DYE

Quantity affected

2 units

Distribution

Distributed in the states of MD and TX.

Date initiated

2014-08-15

Date posted

2014-09-11

Date terminated

2014-11-06

Location

Santa Ana, CA