Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medline Sprinter OTW Recalled by Medtronic Inc Due to Luer has balloon diameter printed as "2.25mmx12mm" instead...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc directly.
Affected Products
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.
Quantity: 84 units
Why Was This Recalled?
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc
Medtronic Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report