Recall archive
28 recalls · page 2 of 2
Reported Jul 19, 2023
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand · Product · Product details — There was one complaint that the sidearm of the device detached during explant of a pump. When the sidearms are subjected to heat, humidity and…
FDA (openFDA device enforcement)
Reported May 24, 2023
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
FDA (openFDA device enforcement)
Reported Feb 9, 2022
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abiomed, Inc.
Matched: Brand — The firm has received complaints of the OXY-1 System Console experiencing a power interruption while in use, which disrupts therapy delivered to a…
FDA (openFDA device enforcement)
Reported Nov 13, 2019
lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support blood pump, for Use During Cardiogenic Shock…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abiomed, Inc.
Matched: Brand — This one pump shipped with incorrect pump programming, the initial production working version of the program. The pump would have immediately run at…
FDA (openFDA device enforcement)
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