FDASeptember 3, 2019device

Solarice Rapid Exchange Balloon Dilatation Catheter, Product Numbers: SLC1506X, SLC1510X, SLC1512X, SLC1515X, SLC1520X, SLC2006X, SLC2010X, SLC2012X, SLC2015X, SLC2020X, SLC2025X, SLC2030X, SLC22510X, SLC22515X, SLC22520X, SLC22525X, SLC2506X, SLC2510X, SLC2512X, SLC2515X, SLC2520X, SLC2525X, SLC...

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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