FDAJuly 13, 2017device

Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

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

The hazard

Stylette removal difficulties on the Euphora and Solarice products.

What to do

FDA enforcement status: Terminated

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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