FDA-Device2021-07-21Class II
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.
Heartware, Inc.
Hazard
The pump has an impeller with a shroud height that did not meet the lower control limit.
Sold states
International distribution to the country of Germany.
Affected count
1 unit
Manufactured in
14400 Nw 60th Ave, Miami Lakes, FL, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2072-2021Don't want to check this manually?
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