FDA recall Z-2058-2020

Heartware, Inc. · Class I · device

Product

Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125

Reason for recall

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.

Distribution

Worldwide Distribution

Key facts

Status
Ongoing
Initiation date
2020-04-03
Report date
2020-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2058-2020