Heartware recalls HVAD Pump Implant accessories (REF 1153) due to potential tears in the Outflow Graft and Strain Relief screw breaking during pre-implant assembly. All units distributed are affected.
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 Implant accessories (product REF 115:3) because the Outflow Graft can tear and the Strain Relief screw may break during pre-implant assembly. This could lead to complications for patients with heart failure devices.
The Outflow Graft may tear during assembly, and the Strain Relief screw can break, potentially causing leaks or device malfunction in patients with heart failure devices.
Patients with Heartware HVAD pumps who have the recalled accessories are affected. Those who have undergone pre-implant assembly with these parts are at higher risk.
Check for Heartware HVAD Pump Implant accessories with product reference number 1153. All lot numbers distributed are affected, so any units purchased are included.
Look for Heartware HVAD Pump Implant accessories with product reference number 1153. All lot numbers distributed are affected.
Heartware HVAD Pump Implant accessories with product reference number 1153.
The Outflow Graft may tear and the Strain Relief screw may break during pre-implant assembly.
The recall does not specify a stop-use instruction; check for the product reference number to confirm if you have the recalled items.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2059-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2059-2020 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.
