FDAFDA · Food and drugs·Recall number Z-2190-2021
HeartWare HVAD Pump Implant Kit, REF 1125
Published August 18, 2021 · Recall initiated: June 3, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Heartware, Inc.
- Distributor
- 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.
- Lot
- GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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