Is HeartWare HVAD Pump Implant Kit, REF 1103 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. Status: Voluntary: Firm initiated Initial Firm Notification: Letter 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.

Critical RiskFDA Device

Heartware, Inc.: 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.

Agency Publication Date: August 6, 2021

Affected Products

Product: HeartWare HVAD Pump Implant Kit, REF 1103

GTIN: 00888707003261 All serial numbers

Product: HeartWare HVAD Pump Implant Kit, REF 1104

GTIN: 00888707003063, 00888707003070, 00888707006323, 00888707003117, 00888707006392, 00888707006408, 00888707006330, 00888707003100, 00888707003254, 00888707009140, 00888707007290, 00888707006446, 00888707008129, 00888707002608, 00888707008174, 00888707003209, 00888707006347 All serial numbers

Product: HeartWare HVAD Pump Implant Kit, REF 1125

GTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers

Product: HeartWare HVAD Pump Implant Kit, REF 1153

GTIN: 00888707000147 All serial numbers

Product: HeartWare HVAD Driveline Extension Cable, REF 100

GTIN: 00888707009294, 00888707000345, 00763000187651 All serial numbers

Product: HeartWare HVAD Driveline Extension Cable, REF 100US

GTIN: 00888707000024 All serial numbers

Product: HeartWare HVAD Implant Kit, REF 1104JP

GTIN: 00888707005838 All serial numbers

Product: HeartWare HVAD Implant Kit, REF MCS1705PU

GTIN: 00888707005715, 00888707007160, 00888707007139, 00888707005364, 00888707009041 All serial numbers

Product: HeartWare HVAD Outflow Graft, REF MCS1725OG

GTIN: 00888707007627, 00888707007634 All serial numbers

Product: HeartWare HVAD Pump Accessories, REF MCS1753AK

GTIN: 00888707005371, 00888707007597 All serial numbers

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88197

Status: Active

Manufacturer: Heartware, Inc.

Manufactured In: United States

Units Affected: 10 products (647 units; 943 units; 4078 units; 163 units; 338 units; 443 units; 63 units; 439 units; 459 units; 76 units)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.