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Abiomed, Inc. recalls Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Recalled July 19, 2023 · FDA recall Z-2128-2023 · Abiomed
Hazard
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. · FDA Class II
Units
37 units
Sold at
US Nationwide distribution in the states of MN, NJ, TN.
Description
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.
Product
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Manufacturer(s)
Abiomed, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →