Medtronic Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Medtronic Inc
Lot Codes / Batch Numbers
GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
Products Sold
GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
Medtronic Inc is recalling Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation c due to Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
Recommended Action
Per FDA guidance
The firm issued a recall notice on 06/24/2022 by US Mail. Instruction to Customers: 1. Identify and quarantine all unused affected products. 2. Return all unused affected products in your inventory to Medtronic for replacement product or destroy all unused affected products in your inventory at your location. To initiate a product return contact Medtronic Customer Service at 800-854-3570. You local Medtronic Representative can assist you as necessary in initiating the return of this product. 3. Complete the enclosed Customer Confirmation Form and email it to rs.cfqfca@medtronic.com. 4. Consignees are asked to forward the notification to those who need to be aware within the organization and to any location which the devices have been distributed.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026