Reported Jul 21, 2021 · Ongoing
HeartWare, HVAD Pump Implant Kit, REF MCS1705PU - Product Usage: indicated for hemodynamic support in patients with…
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- HeartWare, HVAD Pump Implant Kit
- REF MCS1705PU - Product Usageindicated 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
- Lot codes and dates
- UDI00888707007139. Serial Number HW42843
- Amount recalled
- 1 unit
Why it was recalled
The pump has an impeller with a shroud height that did not meet the lower control limit.
This product could cause temporary or reversible health problems — stop using it.
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