HeartWare Ventricular Assist Device (HVAD) System
This recall is currently active, issued January 27, 2022. It was issued by Heartware, Inc..
- Company
- Heartware, Inc.
- Recall Initiated
- January 27, 2022
- Recall Number
- Z-0726-2022
- Quantity
- 197,889 units
- Firm Location
- Miami Lakes, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
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
Root Cause
Labeling design
Action Taken
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.