FDA-Device2023-07-19Class II
Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457
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-2128-2023More Abiomed, Inc. recalls
- FDA-Device2026-06-03Abiomed Impella Controller recalled for alarm failures and cassette misalignment
- FDA-Device2026-06-03Abiomed Impella Controller recalled for hardware defects affecting motor control and device function
- FDA-Device2026-04-08Abiomed Impella Controller recalled for delayed alarm display with Impella 5.5 pumps
- FDA-Device2026-04-08Abiomed Impella Pump Set purge cassettes recalled for increased leak risk
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