Heartware recalls HVAD Pump Implant Kit (REF 1104) due to risk of outflow graft tears and strain relief screw breakage during pre-implant assembly. Affected units have specific serial numbers and GTINs listed in the recall notice.
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 Kit (Product REF 1104) because the outflow graft may tear and the strain relief screw may break during pre-implant assembly. This could lead to complications during the implant procedure.
During the pre-implant assembly process, the outflow graft can tear and the strain relief screw can break. This could cause complications during the implant procedure, potentially leading to device failure or requiring additional surgical intervention.
Patients who have received this specific implant kit for heart failure treatment are most at risk. The recall affects individuals who have the listed serial numbers and GTINs.
Check if your Heartware HVAD Pump Implant Kit has the Product REF 1104 with the serial numbers listed in the recall notice (e.g., HW28848, HW29011, etc.) or the specified GTINs.
Review your implant kit's serial numbers and GTINs to confirm if they match the recalled list provided in the notice.
Reach out to Heartware directly for guidance on next steps if your kit is affected.
This recall specifically applies to Heartware HVAD Pump Implant Kits with Product REF 1104 and the listed serial numbers and GTINs. If your device matches these details, it is affected.
Check your serial numbers and GTINs against the list provided in the recall notice. If affected, contact Heartware for further instructions.
The recall does not require immediate discontinuation of use but requires verification of the kit's serial numbers and GTINs to ensure safety during the implant procedure.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2056-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2056-2020 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.
