Z-2623-2014 Class II Terminated

Recalled by Medtronic Cardiovascular Surgery-the Heart Valve Division — Santa Ana, CA

FDA device recall Z-2623-2014 was initiated by Medtronic Cardiovascular Surgery-the Heart Valve Division on August 15, 2014 and is designated Class II. Reason for recall: Medtronic has decided to discontinue production and distribution of this low-volume product. The recall status is terminated (terminated November 6, 2014). Affected quantity: 2 units.

Recall Details

Product Type
Devices
Report Date
September 17, 2014
Initiation Date
August 15, 2014
Termination Date
November 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.

Reason for Recall

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

Distribution Pattern

Distributed in the states of MD and TX.

Code Information

Serial Numbers: B146341, B146350