Class 1 Device Recall HeartWare

• Date Initiated by Firm: April 29, 2015
• Date Posted: May 14, 2015
• Recall Status: Open, Classified
• Recall Number: Z-1604-2015
• Recall Event ID: 71099
• 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: Catalog #: ASY00116: HVAD Pump Driveline Splice Kit Lot #'s 532770, 567949, 480786, 483769, 490692, 539664, and 598189 and Catalog #: ASY00281: HVAD Pump Driveline Splicekit; Large OD Sheath Lot #'s 654090, 672401, 678800, 690423, 833963, 873159, and 880816
• Recalling Firm/ Manufacturer: HeartWare Inc; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: Clinical Support; 305-364-1575
• Manufacturer Reason for Recall: Failures of the splice repair kit if exposed to excessive force.
• FDA Determined Cause: Device Design
• Action: HeartWare, Inc. sent an Urgent Medical Device Correction letter to all affected consignees on May 11, 2015. The letter identified the affected product, problem, and actions to be taken by the consignees. The firm requested that consignees: 1) review the notice and the Patient Communication contents, 2) forward the notice to individuals within their organization who need to be aware of the notice, 3) identify patients that are currently on support and have undergone a driveline splice repair, 4) distribute the Patient Communication to the affected patients in person, 5) continue to reinforce the messages described in the notice with patients who have experienced a splice repair during their regularly scheduled appointments, 6) complete, sign, and return the "Acknowledge and Completion Form to HeartWare within 30 days of receipt of the letter. Should any questions or concerns arise, please contact there local HeartWare representative. Their 24-hour Clinical Support personnel are also available at 1 (888) 494-6365.
• Quantity in Commerce: 35
• Distribution: Worldwide Distribution - US Nationwide in the states of FL, KY, MO, NY, TN,TX, and the countries of: Canada, Germany, Italy, Netherlands, Turkey and United Kingdom.
• 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