HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU

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.

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.