Class 1 Device Recall HeartWare HVAD Pump Implant Kit

• Date Initiated by Firm: April 14, 2022
• Create Date: June 03, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1207-2022
• Recall Event ID: 89966
• PMA Number: P100047
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
• Code Information: a) Model Number 1104JP: GTIN: 00763000170967 Serial numbers: HW41784, HW41825, HW41829, HW41849, HW41852, HW41853, HW41863, HW42312, HW42352, HW42775, HW42818, HW42879, HW42882, and HW42884. b) Model Number MCS1705PU: GTIN 00888707005364, Serial Numbers: HW42448 and HW42571; GTIN 00888707007139, Serial Numbers: HW42955 and HW42962; GTIN 00888707009041, Serial Numbers HW43483 and HW43484; and GTIN 00888707003070, Serial number HW42153.
• Recalling Firm/ Manufacturer: Medtronic Inc; 710 Medtronic Pkwy Mailstop Ls245; Minneapolis MN 55432-5603
• For Additional Information Contact: MCS Customer Service; 877-367-4823
• Manufacturer Reason for Recall: The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm issued letters flagged "Urgent Medical Device Recall" dated April 2022 on 4/14/2022 via 2-day UPS delivery. The letter provided the issue description and requested the consignee to take the following actions: Immediately quarantine and return the unused affected product, complete the enclosed Customer Confirmation Form and email it to the firm, share the notice with all those who need to be aware within their organization or to any organization where the existing product has been transferred, and retain the notification for their records regarding the retrieval of the unused affected product. The Customer Confirmation Form confirms the consignee has read the letter and taken appropriate action. The consignee is to indicate the product and serial number that is being returned. The consignee is also supposed to list the product and serial number of the HVAD Pump implant kits that have been implanted. Return instructions are also provided. Beginning April 26, 2022, the firm send a follow-up communication to all VAD centers with patients on support to communicate that this retrieval has been conducted as well as informing them of the ongoing investigation and providing patient management recommendations.
• Quantity in Commerce: 21 pump implant kits
• Distribution: Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
• 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