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U.S. Department of Health and Human Services

Class 2 Device Recall Hancock Apical Left Ventricular Connector (LV Connector)

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  Class 2 Device Recall Hancock Apical Left Ventricular Connector (LV Connector) see related information
Date Initiated by Firm August 15, 2014
Date Posted September 11, 2014
Recall Status1 Terminated 3 on November 06, 2014
Recall Number Z-2623-2014
Recall Event ID 69089
PMA Number P870078 
Product Classification replacement Heart-valve - Product Code DYE
Product 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.
Code Information Serial Numbers: B146341, B146350
Recalling Firm/
Manufacturer		 Medtronic Cardiovascular Surgery-the Heart Valve Division
1851 E Deere Ave
Santa Ana CA 92705-5720
For Additional Information Contact
949-474-3943
Manufacturer Reason
for Recall		 Medtronic has decided to discontinue production and distribution of this low-volume product.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 2 units
Distribution Distributed in the states of MD and TX.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = DYE and Original Applicant = Medtronic, Inc.
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