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.
FDA Recall Z-2623-2014 · Posted 2014-09-11
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Recall StatusTerminated
Product CodeDYE
Date Initiated2014-08-15
Date Terminated2014-11-06
Product Quantity2 units
Reason for Recall
Medtronic has decided to discontinue production and distribution of this low-volume product.
Firm Action
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 [email protected] or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.
Root Cause
Component design/selection
Distribution Pattern
Distributed in the states of MD and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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