Heartware recalls HVAD Pump Accessories REF MCS175: Neurological adverse events and mortality risks identified in clinical studies. Affected units include specific serial numbers and GTINs.
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 HVAD Pump Accessories with serial number REF MCS1753AK due to higher rates of neurological issues and deaths compared to other ventricular assist devices. This recall is based on clinical observations and user reports of pump failures.
The HVAD system has been linked to neurological adverse events and higher mortality rates compared to other ventricular assist devices. Additionally, users have reported that the internal pump may delay or fail to restart, potentially causing serious complications.
Patients using Heartware's HVAD system with the specific serial number REF MCS1753AK are most at risk. The recall affects individuals who have received this model for left ventricular assist therapy.
Check for the serial number REF MCS1753AK on your Heartware HVAD Pump Accessories. The product also has GTIN numbers 00888707005371 and 00888707007597.
Look for the serial number REF MCS1753AK on your Heartware HVAD Pump Accessories.
Heartware is recalling these pump accessories due to higher rates of neurological adverse events and mortality compared to other ventricular assist devices, as well as reports of pump failures.
Check your serial number to see if it matches REF MCS1753AK. If so, contact Heartware for further instructions.
Yes, the pump may delay or fail to restart, which could lead to serious complications. The recall is based on clinical observations and user reports.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2197-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2197-2021 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.
