FDA-Device2021-08-18Class I
HeartWare HVAD Pump Accessories, REF MCS1753AK
Heartware, Inc.
Hazard
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.
Sold states
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, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
Affected count
76 units
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
HeartWare HVAD Pump Accessories, REF MCS1753AK
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2197-2021Don't want to check this manually?
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