HeartWare HVAD Pump Implant Kit, REF 1125
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 implant kit, worldwide. The company is taking this action 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.
Approximately 4,078 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 affected product is identified by GTINs 00888707000222, 00888707007641, and 00888707005685, with all serial numbers included in the recall. The source does not specify what remedy an affected consumer should pursue.
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: 4078 units Lot/code info: GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.