HeartWare HVAD Driveline Extension Cable, REF 100
Check against the official notice below — it lists the full affected range.
Medtronic is stopping distribution and sale of the HVAD System worldwide, including throughout the United States and in numerous countries across Europe, the Middle East, Africa, and Asia. The company is halting sales due to clinical comparisons showing 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, users have reported that the internal pump may delay or fail to restart.
Approximately 338 units of the HeartWare HVAD Driveline Extension Cable have been distributed. The affected product can be identified by the following GTINs: 00888707009294, 00888707000345, and 00763000187651, with all serial numbers included in the recall. The source document does not specify what remedy consumers 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: 338 units Lot/code info: GTIN: 00888707009294, 00888707000345, 00763000187651 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.