medical Class II Updated 2023-07-19

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

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 00813502013252; Lot Numbers: 1727033, 1725590
View official government recall

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