Heartware recalls HVAD Pump Implant Kit (REF 1103) 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. Consumers should check their device details and contact Heartware for guidance.
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 1103) 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. If you own this device, you should check if your unit is affected and contact Heartware for instructions.
During the pre-implant assembly process, the outflow graft may tear and the strain relief screw may break. This could cause complications during the implant procedure, potentially leading to device failure or additional medical issues.
Patients who have this specific HVAD Pump Implant Kit (REF 1103) for heart failure treatment are most at risk. The recall affects individuals who have undergone or are scheduled for implant procedures using this model.
Check if your device has the Product REF 1103 label, GTIN 00888707000017 or 00888707002639, and the listed serial numbers (e.g., HW26899, HW27283, etc.). The recall includes specific serial numbers and GTINs provided in the official notice.
Review your device's serial number and GTIN to confirm if it matches the listed affected units.
Reach out to Heartware directly for guidance on next steps and potential remedies.
Check your device's serial number and GTIN against the list provided in the recall notice to determine if it's affected.
Contact Heartware directly for instructions on how to proceed with the recall.
The recall does not specify a fix; Heartware will provide guidance on next steps.
We’ve drafted a message you can send Heartware to request your refund or repair — edit it as you like.
Subject: Recall Z-2055-2020 — Heartware Heartware Hello, I own a Heartware that is covered by recall Z-2055-2020 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.
