Sprinter recallZ-1483-2022 · Medtronic Inc · initiated Jun 24, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1483-2022
- Status
- Open, Classified
- Initiated by the company
- Jun 24, 2022
- Recalling firm
- Medtronic Inc
- Quantity
- 84 units
- Product code
- LOX
- FDA submissions
- P790017S081
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sprinter™ SPR2512WMedtronic, Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page