Medtronic recalls Sprinter OTW catheter model SPR2512W due to incorrect balloon size labeling on the Luer connector. This may lead to improper sizing during procedures. Affected units were sold with specific lot numbers.
Medtronic is recalling the Sprinter OTW balloon dilatation catheter (model SPR2512W) because the Luer connector incorrectly shows a balloon size of 2.25mmx12mm instead of the correct 2.5mmx12mm. This labeling error could cause improper catheter sizing during medical procedures, potentially leading to complications. Read more at govinfonow.com/recall/60436-medtronic-sprinter-otw-catheter-recall-incorrect-balloon-size-labeling.
“Medtronic Sprinter OTW Catheter Recall: Incorrect Balloon Size Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60436-medtronic-sprinter-otw-catheter-recall-incorrect-balloon-size-labeling. Based on FDA recall #Z-1483-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1483-2022%22&limit=1).
The FDA announced on June 24, 2022, that Medtronic Inc. is recalling the Medline Sprinter OTW balloon dilatation catheter due to incorrect labeling of the balloon diameter. The hazard involves a Luer marked with the wrong dimensions compared to the outer packaging.
How to tell if you have it
Brand: Medline
Product: Sprinter OTW, Model/Catalog Number SPR2512W
GTIN/UPN: 00643169850491
Lot Number: 222066656
Expiration Date: 04/13/2023
Units affected: 84
The hazard
The Sprinter Over-the-Wire balloon dilatation catheter has a Luer with the balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Recent Medtronic recalls include the Sphere-9 Catheter Recall (2026-03-11) and the Abre Venous Stent Recall (2025-12-04). Other recent recalls of similar products include the Olympus Nephro-EZDilate Catheter Kit (2025-10-17), the Diversatek Viper 3-Stage Balloon Dilator Recall (2026-03-18), and the Olympus EZDilate Balloon Dilator Recall (2026-08-19).
How to tell if you have this one
Check for the model number SPR2512W on the catheter's packaging or label. Affected units were sold with lot number 222066656 and expired by April 13, 2023.
Brand
Medtronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the model number SPR2512W on the catheter's packaging or label to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1483-2022 (June 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1483-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.