HeartWare HVAD Pump Implant Kit, REF 1103
Reported: August 18, 2021 Initiated: June 3, 2021 #Z-2188-2021
Product Description
HeartWare HVAD Pump Implant Kit, REF 1103
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.
Details
- Recalling Firm
- Heartware, Inc.
- Units Affected
- 647 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, Romania, SAUDI ARABIA, Serbia, Slovakia, SOUTH AFRICA, Spain, Sweden, SWITZERLAND, TAIWAN, Turkey, Ukraine, UNITED ARAB EMIRATES, and United Kingdom.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
HeartWare HVAD Pump Implant Kit, REF 1103. Recalled by Heartware, Inc.. Units affected: 647 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 18, 2021. Severity: Critical. Recall number: Z-2188-2021.
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