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U.S. Department of Health and Human Services

Class 1 Device Recall Heartware Ventricular Assist System

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  Class 1 Device Recall Heartware Ventricular Assist System see related information
Date Initiated by Firm March 10, 2017
Create Date April 25, 2017
Recall Status1 Open3, Classified
Recall Number Z-1832-2017
Recall Event ID 76807
PMA Number P100047 
Product Classification Ventricular (assisst) bypass - Product Code DSQ
Product HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit

Product Usage:
Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit side).
Code Information Product Codes: ASY00116 and ASY00281 Serial # All patients with Drivelines splice repair performed prior April 2015
Recalling Firm/
Manufacturer		 Heartware
14400 NW 60th Ave
Miami Lakes FL 33014-2807
For Additional Information Contact
305-364-1575
Manufacturer Reason
for Recall		 In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to the HVAD Pump Driveline Splice Kit. Medtronic now intends to send a follow-up communication to identified clinicians informing them that a new, improved splice kit is available.
FDA Determined
Cause 2		 Device Design
Action HeartWare, now a part of Medtronic sent an Urgent Medical Device Recall letter on April 2015 and a follow-up letter on March 2017, to customers via overnight mail and/or email.. The letters identified the affected product, problem and actions to be taken. Customers were instructed to review the recall notice, forward the notice to individuals within their organization who need to be aware of the notice, complete, sign, and return the Acknowledgement Form . For questions contact your local HeartWare representative.
Quantity in Commerce 9 units
Distribution Worldwide Distribution - US Nationwide in the states of FL, MO, TN, KY, NY and the country of Germany.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = DSQ and Original Applicant = Medtronic
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