Z-1483-2022Class II

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter...

Name: Z-1483-2022 Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter...
Creator: Medtronic Inc
Published: 2022-06-24
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-06-24 / Open, Classified / root cause: labeling and UDI

FDA source

Medtronic Inc began a recall of 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... on 2022-06-24. FDA classified it as Class II and gives the reason as "Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1483-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-08-01
Recalling firm: Medtronic, Inc.
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.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
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.
Quantity in commerce: 84 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1483-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1483-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-10	2022-08-01

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)