FDA Medical Device Recalls (openFDA)
Heartware Inc: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Recall number
- Z-1323-2013
- Recalling firm
- Heartware Inc
- Product
- Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
- Status
- Terminated
- Initiated
- 2012-12-27
- Posted
- 2013-05-14
- Terminated
- 2013-07-09
- Reason
- HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosening of the HVAD Pump driveline connector.
- Root cause
- Device Design
- Action
- HeartWare, Inc. sent an Urgent Medical Device Correction letter to all their customers on February 7, 2013 instructing that at each routine clinic visit, they should inspect the patient's driveline connector as described in the attached Technical Bulletin. They were asked to sign and return the acknowledgement form to HeartWare. For questions contact your HeartWare representative or Customer Service at 1-877-367-4823.
- Quantity
- 3,544
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of MN, IL, MI, FL, WI, TX, MO, CA, MA, TN, OH, NC, GA, VA, UT, KY, MD, IN, PA, NY, NJ, LA, OR, WA, AL and CO, and the countries of Poland, Australia, Austria, Italy, Germany, New Zealand, South Africa, Czech Republic, France, Brazil, Switzerland, Singapore, United Kingdom, Saudi Arabia, Netherlands, China, Chile, Belgium, Canada, Norway, Lebanon, Israel, Malaysia, Turkey, India, Argentina, Greece, Japan and Lithuania.
- Lot, serial or model codes
- Serial Numbers: United States: HW001-HW3827 and International: HW001-HW3827 and HW1000-HW10675
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- 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