Maquet Datascope Corp - Cardiac Assist Division product recalled over sterility concerns

Recall date

December 16, 2014

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Maquet Datascope Corp - Cardiac Assist Division recalls CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATIO…

Recall number

Z-1062-2015

FDA classification

Class II

Brand / firm

Maquet Datascope Corp - Cardiac Assist Division

Sold / distributed

Worldwide Distribution

Why it was recalled

Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration units. If fiber-optic connector is inserted into the Maquet CS300 or CARDIOSAVE IABP, cap will prevent connection of unit and may become dislodged and remain in IABPs fiber-optic receptacle.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.