FDA recall Z-2128-2023

Product

Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457

Reason for recall

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.

Distribution

US Nationwide distribution in the states of MN, NJ, TN.

Key facts

Status

Ongoing

Initiation date

2023-05-26

Report date

2023-07-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Danvers, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2128-2023