Heartware recalls HVAD Pump Outflow Graft (REF 112:1125) due to potential tears and Strain Relief screw breakage during assembly. Affected units include all lots and serial numbers in distribution.
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Heartware is recalling its HVAD Pump Outflow Graft (product reference 1125) because it can tear or cause the Strain Relief screw to break during the pump assembly process. This could lead to device failure or complications if the pump is not properly assembled.
The outflow graft may tear during the pre-implant assembly process, and the Strain Relief screw can break. This could cause the pump to malfunction or fail, potentially leading to complications for the patient.
Patients with Heartware HVAD pumps who have the recalled outflow graft (product reference 1125) are affected. Those who have undergone pump implantation with this specific graft are most at risk.
Check if your Heartware HVAD Pump Outflow Graft has product reference number 1125. All lots and serial numbers in distribution are affected.
Identify if your Heartware HVAD Pump Outflow Graft has product reference number 1125.
This recall specifically affects the Heartware HVAD Pump Outflow Graft with product reference number 1125. If your pump uses this graft, you are affected.
Check if your Heartware HVAD Pump Outflow Graft has product reference number 1125. All lots and serial numbers in distribution are affected.
The recall record does not specify a remedy, so contact Heartware directly for guidance.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2058-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2058-2020 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.
