HeartWare HVAD Driveline Extension Cable, REF 100US
Check against the official notice below — it lists the full affected range.
Medtronic is stopping distribution and sale of the HeartWare HVAD System, a left ventricular assist device used to help the heart pump blood. The company made this decision based on clinical comparisons showing that the HVAD System is associated with a higher frequency of neurological adverse events and deaths compared to other similar devices on the market. Additionally, there have been complaints that the internal pump in the device may delay or fail to restart.
Approximately 443 units of the HVAD Driveline Extension Cable have been distributed worldwide, including throughout the United States and in numerous countries across Europe, the Middle East, Asia, and Africa. The recall covers all serial numbers of this product. The source document does not specify what remedy is available to affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart.
Reason for recall: Medtronic is stopping the distribution and sale of the HVAD System due to a growing body of observational clinical comparisons that shows a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available left ventricular assist devices, as well as complaints that the internal pump may delay or fail to restart. Distribution: Worldwide distribution. US nationwide and Armenia, AUSTRIA, Bahrain, Belgium, CROATIA, CZECH REPUBLIC, Denmark, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, Hungary, Israel, ITALY, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, LITHUANIA, LUXEMBOURG, Macedonia, NETHERLANDS, Norway, POLAND, Qatar, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Quantity: 443 units Lot/code info: GTIN: 00888707000024 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.