FDA Medical Device Recalls (openFDA)
Heartware, Inc.: HeartWare Ventricular Assist Device (HVAD) System
- Recall number
- Z-0726-2022
- Recalling firm
- Heartware, Inc.
- Product
- HeartWare Ventricular Assist Device (HVAD) System
- Status
- Open, Classified
- Initiated
- 2022-01-27
- Posted
- not on file
- Terminated
- not on file
- Reason
- Updated cleaning instructions are being provided for the Controller AC Adapter, DC Adapter, and Battery to provide clarity to avoid cleaning the power source connector pins, as this could remove the lubricant that is applied to the pins as a mitigation for power switching.
- Root cause
- Labeling design
- Action
- Starting 27-Jan-2022 and ending 02-FEB-2022, Medtronic initiated an Urgent Medical Device Notice to global customers to inform them of the intent to update the cleaning instructions for power source connector pins on the HVAD" System Monitor AC Adapter, DC Adapter, and Batteries. The communication provided customers the updated instructions, the complaints received as well as the potential hazards of cleaning the power source connector pins. In addition to the Urgent Medical Device Notice a patient template was provided to facilitate the VAD Coordinators in notifying their patients. In the United States the notice was delivered to VAD Coordinators via UPS 2-day delivery. Consignees will be asked to confirm receipt of the letter and that they have acknowledge the actions taken for those nonimplanted, affected product. In addition, a courtesy copy was sent to shared care clinics for those affected patients. Outside the United States the notice will be delivered to consignees through a locally approved method. Consignees will be asked to confirm receipt of the letter and that they have taken the recommended action. Confirmation of the communication will be received by locally approved methods.
- Quantity
- 197,889 units
- Distribution
- Distribution throughout the United States. OUS distribution in Argentina, Armenia, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Kazakhstan, Korea (South), Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Mauritius, Netherlands, New Zealand, North Macedonia, Norway, Pakistan, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Vietnam.
- Lot, serial or model codes
- All lots/serials for the following product model numbers: 1440, 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR, 1425AU, 1425CA, 1425DE, 1425GB, 1425IL, 1425IT, 1425US, 1430AR, 1430AU, 1430CA, 1430CH, 1430DE, 1430GB, 1430IL, 1430IN, 1430IT, 1430JP, 1430US, 1440, 1650, 1650, 1650CA-CLIN, 1650DE
- 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