HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: For use as a bridge-to-cardiac transplantation

FDA device recall Z-1131-2015 · posted 2015-02-25 · Terminated

Recall details

Recalling firm

HeartWare Inc

Reason for recall

The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commercial Controllers.

Action taken

HeartWare sent an URGENT MEDICAL DEVICE RECALL dated January 16, 2015 asking clinicians to quarantine the affected controllers and complete and return the acknowledgement form. HeartWare also asks clinicians to identify patients with affected controllers and review the applicable risks with the patient and as soon as reasonably possible if medically advisable, exchange the affected controller under medical supervision with a new controller. HeartWare also asks that for each patient using an affected controller as their backup to contact the patient and arrange to have the backup controller replaced with a new controller. Lastly, HeartWare asks the firm to complete the patient tracking form and return all quarantined controllers to HeartWare along with the completion form. Should you have any questions or concerns, please contact your local HeartWare representative. Our 24-Hour Clinical Support personnel are also available at 1-888-494-6365.

Root cause

Device Design

Status

Terminated

Product code

DSQ

Quantity affected

4,845

Distribution

Worldwide Distribution - US Nationwide in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NY, OH, OR, PA, TX, UT, VA, WA and District of Columbia and countries of: Canad

Date initiated

2015-01-16

Date posted

2015-02-25

Date terminated

2020-02-05

Location

Miami Lakes, FL