Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HeartWare Recalled by Heartware, Inc. Due to The pump has an impeller with a shroud...
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 Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.
Quantity: 1 unit
Why Was This Recalled?
The pump has an impeller with a shroud height that did not meet the lower control limit.
Where Was This Sold?
International distribution to the country of Germany.
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