HeartWare HVAD Pump Accessories, REF MCS1753AK
Check against the official notice below — it lists the full affected range.
Medtronic has stopped distributing and selling the HVAD System, a left ventricular assist device. The company made this decision based on observational 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.
The recalled product was distributed worldwide, including throughout the United States and in numerous countries across Europe, the Middle East, Africa, and Asia. A total of 76 units with the product codes GTIN 00888707005371 and 00888707007597 (all serial numbers) are affected. The recall source does not specify what remedy or action affected consumers should take.
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: 76 units Lot/code info: GTIN: 00888707005371, 00888707007597 All serial numbers
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.