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

FDA device recall Z-1698-2015 · posted 2015-06-08 · Open, Classified

Recall details

Recalling firm

HeartWare Inc

Reason for recall

HeartWare has received complaints relating to damage or bent connection pins within the power supply ports of the VAD controller.

Action taken

HeartWare sent an Urgent Medical Device Correction letter to customers on May 25, 2015. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Review the enclosed notice and Patient Communication. 2. Forward the notice to those individuals within their organization who need to be aware of its contents. 3. Identify the patients currently supported by the HVAD System. 4. Distribute the "Patient Communication" to their patients directly via FedEx or some other reliable means of communication. 5. Continue to reinforce the messages set forth in the notice with their patients during their regularly scheduled appointments. 6. Complete, sign and return the Acknowledgement and Completion Form to HeartWare within 30 days of receipt of this letter. For questions contact your local HeartWare representative or the 24-Hour Clinical Support personnel at 1-888-494-6365.

Root cause

Device Design

Status

Open, Classified

Product code

DSQ

Quantity affected

3,747 currently implanted worldwide

Distribution

Worldwide Distribution - US Nationwide in 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, VA and countries of

Date initiated

2015-04-29

Date posted

2015-06-08

Location

Miami Lakes, FL