Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
HeartWare HVAD Pump Implant Kit Recalled by Medtronic Inc Due to The pump may have a welding defect that...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc directly.
Affected Products
HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Quantity: 21 pump implant kits
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc
Medtronic Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report