FDASeptember 3, 2019device

Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X, EUP2006X, EUP2010X, EUP2012X, EUP2015X, EUP2020X, EUP2025X, EUP2030X, EUP22506X, EUP22510X, EUP22512X, EUP22515X, EUP22520X, EUP22525X, EUP2506X, EUP2510X, EUP2512X, EUP2515X, E...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

What to do

FDA enforcement status: Ongoing

Brands named

medtronic vascular galway dba medtronic irelandmedtronicmedtronic vascular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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