Recall Z-2197-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
| Date | Jun 3, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | In the United States, beginning 03-Jun-2021, this notice was delivered to Risk Managers via UPS 2-day delivery in the United States as well as through verbal and in person follow ups from the Medtronic field staff. In addition, a courtesy copy was sent to all implanting and following physicians via UPS 2-day delivery. Finally, an e-mail notice was sent as a courtesy copy to all consignees who had opted into communication from Medtronic. Medtronic began an additional communication on 7 July 2021 to all consignees who, according to Medtronic records had unexpired product (see Attachment D Pr |
| Quantity | 76 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.