HeartWare HVAD Outflow Graft, REF MCS1725OG
Check against the official notice below — it lists the full affected range.
Medtronic is stopping distribution and sale of the HeartWare HVAD System worldwide, including throughout the United States and numerous international locations. The company made this decision based on observational clinical data 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. Approximately 459 units with the affected GTINs and all serial numbers are involved in this recall.
The source document does not specify a remedy or corrective action 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: 459 units Lot/code info: GTIN: 00888707007627, 00888707007634 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.