Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartWare HVAD Pump Kit Recalled by Heartware, Inc. Due to Over time, the driveline cover may become hardened,...
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 Heartware, Inc. directly.
Affected Products
HeartWare HVAD Pump Kit, REF 1103
Quantity: 5704 units
Why Was This Recalled?
Over time, the driveline cover may become hardened, creating difficulty or an inability to slide the cover back to access the driveline to controller connector. Access to the driveline connector may be delayed, which may result in patient harm from a prolonged pump stop, if an urgent driveline connection or controller issue needs to be addressed. In the event a hardened driveline cover is observed, contact your Medtronic field representative for further assessment and/or servicing.
Where Was This Sold?
Worldwide distribution.
About Heartware, Inc.
Heartware, Inc. has 60 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report