FDA recall Z-1483-2022

Medtronic Inc · Class II · device

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 for recall

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

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-06-24
Report date
2022-08-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1483-2022