FDA Medical Device Recalls (openFDA)
HeartWare Inc: HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
- Recall number
- Z-1917-2015
- Recalling firm
- HeartWare Inc
- Product
- HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
- Status
- Open, Classified
- Initiated
- 2015-04-29
- Posted
- 2015-06-26
- Terminated
- not on file
- Reason
- Complaints with the HVAD Abnormal Power Source Switching.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 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, Belgium, Brazil, Canada, Chile, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zealand, Norway, Poland, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, and UK.
- Lot, serial or model codes
- Catalog #'s US: 1101 and 1103 / OUS: 1100,1101,1102,1104,1104JP and 1205. Serial #: ALL HeartWare HVAD systems currently in use.
- 510(k) numbers
- not on file
- PMA numbers
- ["P100047"]
- Product code
- DSQ
- Firm FEI
- 3007042319
- Firm city
- Miami Lakes
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28