HeartWare HVAD Pump Implant Kit, REF 1103
Check against the official notice below — it lists the full affected range.
Medtronic has stopped distributing and selling the HeartWare HVAD System, a left ventricular assist device implant kit. 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 mortality compared to other commercially available left ventricular assist devices. Additionally, there have been complaints that the internal pump may delay or fail to restart.
A total of 647 units of the HVAD System have been distributed worldwide, including throughout the United States and in numerous countries across Europe, the Middle East, Africa, and Asia. The recall applies to all serial numbers of the product (GTIN: 00888707003261). The source document does not specify a remedy or instructions for 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: 647 units Lot/code info: GTIN: 00888707003261 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.