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Cordis Corporation recalls Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Recalled August 18, 2021 · FDA recall Z-2235-2021 · Cordis
Hazard
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon. · FDA Class II
Units
8 units
Sold at
Worldwide distribution - US Nationwide distribution in the states of CA, OH, and the countries of Switzerland, Portugal, and Poland.
Description
The balloon protective sheath may potentially be contaminated with a foreign material left over from the manufacturing process. The contaminant may transfer over from the sheath to the balloon.
Product
Cordis SABER PTA Balloon Dilation Catheter, 4F, REF 48004010X
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →