FDA-Device2023-07-19Class II
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Abiomed, Inc.
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.
Sold states
US Nationwide distribution in the states of MN, NJ, TN.
Affected count
37 units
Manufactured in
24 Cherry Hill Dr, N/A, Danvers, MA, United States
Products
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2023Don't want to check this manually?
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