Heartware recalls HVAD Pump Implant Kit REF MCS170: Impeller shroud height may not meet safety limits. Affected patients should contact Heartware for guidance.
The pump has an impeller with a shroud height that did not meet the lower control limit.
Heartware is recalling its HVAD Pump Implant Kit (REF MCS1705PU) because the pump's impeller shroud height might be too low, potentially causing safety issues. This recall affects patients with advanced heart failure who use the device for hemodynamic support.
The pump's impeller shroud height did not meet the lower control limit, which could lead to improper function. This might cause the device to fail in supporting heart function, especially in patients with severe heart failure.
Patients with advanced, refractory left ventricular heart failure who use the Heartware HVAD Pump Implant Kit for hemodynamic support are affected. Those who have the specific model REF MCS1705PU are most at risk.
Check for the product name 'Heartware HVAD Pump Implant Kit' and the serial number HW42843. The recall applies to the specific model REF MCS1705PU used for hemodynamic support in advanced heart failure patients.
Reach out to Heartware directly for guidance on the recall and next steps.
No, this recall specifically affects patients with advanced, refractory left ventricular heart failure using the Heartware HVAD Pump Implant Kit for hemodynamic support.
Contact Heartware directly for guidance on the recall and next steps.
Check for the product name 'Heartware HVAD Pump Implant Kit' and the serial number HW42843. The recall applies to the specific model REF MCS1705PU.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2072-2021 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2072-2021 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.
