Product Safety Recalls

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Heartware, Inc. Recall 88197

Description: HeartWare HVAD Pump Implant Kit, REF 1125

Heartware, Inc. Recall 88197 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2190-2021
Event ID88197
Event DescriptionHeartWare HVAD Pump Implant Kit, REF 1125
Product TypeDevices
DistributionWorldwide 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.
Quantity4078 units
Recall ReasonMedtronic 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.
Device Classification20210818
Device Code InfoGTIN: 00888707000222, 00888707007641, 00888707005685 All serial numbers
Center Classification Date20210806
Recall Initiation Date20210603
Recalling FirmHeartware, Inc.
Initial Notification Letter
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