FDA-Device2020-06-03Class I
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Heartware, Inc.
Hazard
The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-implant pump assembly and attachment to the HVAD Pump.
Sold states
Worldwide Distribution
Affected count
560 units
Manufactured in
14400 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Heartware HVAD Pump Implant accessories, Product (REF) Number 1153
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2059-2020Don't want to check this manually?
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