—#194755

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.

FDA product code: LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
Device class: Class 2
Medical specialty: Cardiovascular
PMA numbers: P790017S081
Affected lot / code info: GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 710 Medtronic Pkwy, Mailstop Ls245, Minneapolis, Minnesota 55432-5603

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2022-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194755. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.