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.
This recall has been terminated (originally issued September 11, 2014).
- Recall Initiated
- August 15, 2014
- Posted
- September 11, 2014
- Terminated
- November 6, 2014
- Recall Number
- Z-2623-2014
- Quantity
- 2 units
- Firm Location
- Santa Ana, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic has decided to discontinue production and distribution of this low-volume product.
Distribution
Distributed in the states of MD and TX.
Lot / Code Info
Serial Numbers: B146341, B146350
Root Cause
Component design/selection
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.