Class 2 Device Recall HeartMate Touch Communication System

• Date Initiated by Firm: October 22, 2021
• Create Date: November 26, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0308-2022
• Recall Event ID: 88876
• Product Classification: Ventricular (assist) bypass - Product Code DSQ
• Product: Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: Thoratec Corp.; 6035 Stoneridge Dr; Pleasanton CA 94588-3270
• For Additional Information Contact: Brent Tippen; 512-286-4217
• Manufacturer Reason for Recall: If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
• FDA Determined Cause: Software design
• Action: On 10/22/21, correction notices were provided via site visit, or email. Until the resolution is provided, the recalling firm is requesting that your facility retain or obtain the System Monitor II (Model Numbers 1286 and L1286) and ensure it is readily available for use in the event that the LVAS communication system is unable to function properly. The recalling firm is extending the support and servicing of System Monitors II until this issue is resolved and the resolution is fully implemented in the field. If your facility does not have a System Monitor II, the recalling firm will provide a loaner System Monitor II at no charge until a corrective action is provided to your facility. If your facility has not previously used a System Monitor II, the recalling firm will provide training and implementation support to your facility. A firm representative will work with you to schedule a time that is convenient for you and your staff. If you have any questions about this communication or the recommendations, please contact your local representative or Technical Support at 1-800-456-1477 (U.S.). Please share this notice with all those within your organization who might operate the affected device. We ask that you maintain a record of this notice to ensure effectiveness of the communication. Please complete and return the response form.
• Quantity in Commerce: 988
• Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, IL, PA, AR, GA, WI, AZ, TN, TX, MA, NE, CA, VA, NC, OH, MI, DC, IN, NJ, CT, OK, MD, NY, ME, IA, SC, KY, LA, OR, NM, WA, SD, MO, NV, HI, AL, MS, UT, KS and the countries of AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ISRAEL, ITALY, KUWAIT, LITHUANIA, NETHERLANDS, NEW ZEALAND, POLAND, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, 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.