Recall Z-2623-2014 ยท DYE Replacement Heart-Valve
Medtronic Cardiovascular Surgery-the Heart Valve Division
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.
| Date | Sep 11, 2014 (initiated Aug 15, 2014) |
| Status | Terminated |
| Reason | Medtronic has decided to discontinue production and distribution of this low-volume product. |
| Root cause | Component design/selection |
| 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 custom |
| Quantity | 2 units |
| Distribution | Distributed in the states of MD and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.