Medtronic recalls HeartWare HVAD Pump Implant Kit models 1104JP and MCS1705PU due to suspected welding defects that could cause pump malfunction and affect blood flow.
The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
Medtronic is recalling two specific HeartWare HVAD pump implant kits (model numbers 1104JP and MCS1705PU) because a welding defect might allow moisture to enter and corrode internal components, potentially disrupting blood flow. This could lead to symptoms similar to pump thrombosis, though the issue is under investigation.
A suspected welding defect on the center post cap could allow moisture to enter the pump, corroding magnets that keep the impeller rotating properly. This might cause unintended contact between the center post and impeller, disrupting blood flow through the pump.
Patients with implanted HeartWare HVAD pumps using the specified model numbers are affected. Those with the listed serial numbers or GTINs are most at risk.
Check if your HeartWare HVAD pump implant kit has model number 1104JP with serial numbers listed or model number MCS1705PU with the specified GTINs and serial numbers.
Identify your pump model and serial numbers to see if they match the recalled items listed in the notice.
Medtronic suspects a welding defect on the center post cap that could allow moisture to enter and corrode internal components, potentially disrupting blood flow. The issue is under investigation.
Model numbers 1104JP and MCS1705PU with specific serial numbers and GTINs listed in the recall notice.
The recall notice states no remedy is provided, so affected users should check their product details and contact Medtronic for further guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1207-2022 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1207-2022 from Medtronic. 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.
