Recall Z-1483-2022— Medtronic Inc

Name: FDA recall Z-1483-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-24

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc, initiated 2022-06-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging..

Recalling firm: Medtronic Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-06-24
Firm location: Minneapolis, MN, United States

Product description

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.

Reason for recall

Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.

Data sourced from openFDA. This site is unofficial and independent of the FDA.