HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of

FDA device recall Z-1917-2015 · posted 2015-06-26 · Open, Classified

Recall details

Recalling firm

HeartWare Inc

Reason for recall

Complaints with the HVAD Abnormal Power Source Switching.

Action taken

HeartWare sent an Urgent Medical Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the enclosed Patient Communication and familiarize the contents, forward the notice to those individuals withing their organization who need to be aware of its contents, identify their patients currently supported by the HVAD System, distribute the Patient Communication to their patients via FedEX or some other reliable means of communication. Customers with questions were instructed to contact their HeartWare representative should they need any assistance with the process. Customers were asked to complete, sign, and return the Acknowledgement and Completion Form to HeartWare. Customers with quesitons were instructed to call 1-888-494-6365.

Root cause

Software design

Status

Open, Classified

Product code

DSQ

Quantity affected

3,747 currently in use.

Distribution

US including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA and Internationally to Argentina, Australia, Austria, Belgiu

Date initiated

2015-04-29

Date posted

2015-06-26

Location

Miami Lakes, FL