HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Fo

FDA device recall Z-1731-2015 · posted 2015-06-13 · Open, Classified

Recall details

Recalling firm

HeartWare Inc

Reason for recall

Complaints with the HVAD Internal Controller Alarm Battery failures.

Action taken

Urgent Medical Device Correction letters were sent to customers. The letter identified the affected product, as well as the reason for the recall and risks involved. HeartWare requests that customers review and familiarize themselves with the letter and "Patient Communication," and ensure that all necessary individuals are aware. Patients currently being supported by the device should be identified and given the "Patient Communication." A HeartWare representative can provide assistance with that process if needed. The "Acknowledgement and Completion Form" should be completed, signed, and returned within 30 days of the receipt of the letter. Customers can contact their local HeartWare representative with questions or concerns. Clinical Support personnel are also available at 1-888-494-6365.

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

3,747 curently implanted

Distribution

Worldwide Distribution -- US, including the states of 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, and VA; and, the count

Date initiated

2015-04-29

Date posted

2015-06-13

Location

Miami Lakes, FL