Class 2 Device Recall HVAD Pump Implant Kit

• Date Initiated by Firm: May 28, 2021
• Create Date: July 13, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2072-2021
• Recall Event ID: 88135
• PMA Number: P100047
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
• Code Information: UDI: 00888707007139. Serial Number HW42843
• Recalling Firm/ Manufacturer: Heartware, Inc.; 14400 Nw 60th Ave; Miami Lakes FL 33014-2807
• For Additional Information Contact: MCS Customer Service; 877-367-4823
• Manufacturer Reason for Recall: The pump has an impeller with a shroud height that did not meet the lower control limit.
• FDA Determined Cause: Nonconforming Material/Component
• Action: The firm initiated the recall to the sole consignee on 05/28/2021 by telephone. The consignee was asked to quarantine and return the affected device.
• Quantity in Commerce: 1 unit
• Distribution: International distribution to 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