Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000
Recalled Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Hazard / Issue
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 articulation, a silicone oil contaminant that was unintentionally introduced during manufacturing at the joint between the sidearm and the hub may cause the joint to detach.
Issued by
FDA
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