HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE

FDA device recall Z-1512-2022 · posted 2022-08-18 · Open, Classified

Recall details

Recalling firm

Heartware, Inc.

Reason for recall

Battery performance issues. Battery electrical faults render it unable to power the controller, unable to accept charge from the battery charger, and/or result in the battery to appear to remain charged while discharging.

Action taken

Medtronic (Heartware) issued a Medical Device Correction notice on 06/28/2022 by letter. The notice, addressed to the VAD Coordinators, explained the issues and provided the following recommendations: 1. Please remind your patients to always keep two sources of power connected to their controller and have fully charged spare batteries available at all times. 2. Remind patients to acknowledge and report alarms. 3. Follow the Instructions for Use (IFU) for proper power source management. 4. Inform patients to be vigilant if the battery indicator lights do not decrease over time while the battery is in use. Customer Actions: Complete the enclosed Customer Confirmation Form please return the form to rs.cfqfca@medtronic.com. Please share this letter with all those who need to be aware within your organization or to any organization where patients have been transferred. UPDATE: Medtronic/Heartware issued an Urgent Medical Device notice to its consignees on 05/31/2023 via UPS 2nd day delivery. The notice is a follow-up to Medtronic's existing June 2022 customer notification letter titled "Urgent Medical Device Correction". The notice explained the issue, risk, and announced that Medtronic will begin all batteries for the new batteries with the change to the battery configuration mode. For questions regarding this communication, please contact your local Medtronic Field Representative. Medtronic Patient Services is available to assist patients at 800-635-3930 (Monday-Friday, 8 a.m.-5 p.m. Central Time). For any additional questions you can reach out to the Medtronic Office of Medical Affairs at rs.mcsmedicalaffairs@medtronic.com.

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

19616 batteries

Distribution

Worldwide distribution. US nationwide, Japan, Indonesia, Brazil, Chile, Belgium, Italy, Germany, Switzerland, United Kingdom, Poland, Hungary, Czech Republic, Mauritius, France, South Africa, Greece,

Date initiated

2022-06-28

Date posted

2022-08-18

Location

Miami Lakes, FL