Heartware recalls HVAD Pump Implant Kit (REF 1104JP) due to potential tears in the Outflow Graft and Strain Relief screw breaking during pre-implant assembly. Affected units have specific serial numbers and GTINs.
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 (REF 1104JP) because the Outflow Graft may tear and the Strain Relief screw could break during pre-implant assembly. This poses a risk of complications during the implant procedure.
During the pre-implant assembly process, the Outflow Graft can tear and the Strain Relief screw may break. This could lead to complications during the implant procedure, such as improper device function or the need for additional surgical intervention.
Patients who have received the Heartware HVAD Pump Implant Kit with the specified serial numbers and GTINs are affected. Medical professionals performing the implant procedure are at highest risk.
Check the serial numbers on the kit: HW34700, HW34703, HW34710, HW34713, HW40383, and other listed numbers. The GTIN 00888707000697 or 00888707005838 also identifies affected units.
Compare your kit's serial numbers with the listed affected numbers (e.g., HW34700, HW34713, HW40383).
Reach out to Heartware directly to confirm if your kit is affected and get instructions on next steps.
The product reference number is 1104JP, with specific serial numbers listed in the recall notice.
Check the serial numbers against the list provided: HW34700, HW34703, HW34710, HW34713, HW40383, and other numbers listed in the recall.
The recall does not require immediate discontinuation; affected kits should be checked with Heartware 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-2057-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2057-2020 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.
