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Medtronic Inc recalls Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxia
Recalled August 10, 2022 · FDA recall Z-1483-2022 · Medtronic
Hazard
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging. · FDA Class II
Units
84 units
Sold at
US Nationwide distribution.
Description
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Product
Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Manufacturer(s)
Medtronic Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →