Heartware recalls HVAD Implant Kit REF MCS1705PU due to higher neurological adverse events and mortality risks compared to other ventricular assist devices.
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.
Heartware is recalling its HVAD Implant Kit (REF MCS1705PU) because clinical studies show it has a higher risk of neurological issues and death compared to other left ventricular assist devices. This recall is important because the device's internal pump may also delay or fail to restart, increasing safety concerns.
The Heartware HVAD system has been linked to a higher frequency of neurological adverse events and mortality in clinical studies compared to other left ventricular assist devices. Additionally, the internal pump may delay or fail to restart, potentially causing serious complications.
Patients who have received the Heartware HVAD Implant Kit (REF MCS1705PU) are most at risk. The recall applies to individuals with this specific implant device.
Check for the product name 'Heartware HVAD Implant Kit' with the reference number MCS1705PU. The recall includes specific serial numbers listed in the GTINs provided.
Immediately stop using the Heartware HVAD Implant Kit (REF MCS1705PU) if you have it.
Heartware is recalling the HVAD Implant Kit (REF MCS1705PU) due to clinical studies showing a higher frequency of neurological adverse events and mortality compared to other left ventricular assist devices.
The recall record does not mention any remedy or fix for this device.
Check for the product name 'Heartware HVAD Implant Kit' with reference number MCS1705PU and the specific serial numbers listed in the GTINs provided.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2195-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2195-2021 from Heartware. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
