Class 2 Device Recall HeartWare

• Date Initiated by Firm: November 29, 2022
• Date Posted: December 21, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0742-2023
• Recall Event ID: 91281
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: HeartWare Model 1100
• Code Information: Serial Numbers: HW001, HW012, HW016, HW017, HW023, HW025, HW028, HW044, HW045, HW046, HW047, HW049, HW050, HW051, HW061, HW064, HW083, HW084, HW086, HW091, HW094, HW104, HW105, HW108, HW109, HW110, HW114, HW115, HW116, HW119, HW126, HW127, HW129, HW130, HW131, HW138, HW139, HW143, HW146, HW147, HW153, HW156, HW161, HW170, HW181
• 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: Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
• FDA Determined Cause: Device Design
• Action: The firm issued an URGENT: MEDICAL DEVICE COMMUNICATION to the healthcare providers on 11/29/2022 by UPS 2-day delivery. The letter explained the issue and provided the following: "A. Patient Management Recommendations: In consultation with our Independent Practitioner Quality Panel, Medtronic is providing the following patient management recommendations: "Prior to exchanging a controller in the clinic, check to ensure the driveline cover is not stuck or hardened and can be pulled back from the driveline connector, per the instructions below.This may allow for early detection of the issue if the driveline cover is noticeably harder to manipulate but can still be moved. "During routine clinic visits, check to ensure that the driveline cover is not stuck or hardened and can be pulled back from the driveline connector. Instructions for Evaluating Driveline Cover: While immobilizing the controller, push the driveline towards the controller and pull the driveline cover back from the flange with a side-to-side wiggle motion (this may require support from a second person). DO NOT pull the driveline cover with excessive force or use a twisting motion as this may damage the driveline connector or dislodge the driveline connection. "If it is determined that a driveline cover is hardened or stuck, please contact your Medtronic field representative to evaluate the need to perform a field service procedure to remove the driveline cover. "As a part of the servicing procedure, risks will be discussed to determine the servicing plan, including deciding if the driveline cover will be replaced if removed. If the driveline cover is removed and not replaced, care and maintenance of the driveline will remain the same without a driveline cover, however care should be taken to avoid the ringed, grooved area of the driveline connector unless you intend to disconnect the driveline from the controller. Supplemental labeling information will be provided by the Medtronic field representati
• Quantity in Commerce: 45 units
• Distribution: Worldwide distribution.
• 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.