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.
FDA Recall Z-1483-2022 · Posted None
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Recalling FirmMedtronic Inc
Recall StatusOpen, Classified
Product CodeLOX
Date Initiated2022-06-24
Product Quantity84 units
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.
Firm Action
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 [email protected].
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.
Root Cause
Labeling Change Control
Distribution Pattern
US Nationwide distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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