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U.S. Department of Health and Human Services

Class 2 Device Recall SPRINTER OVERTHEWIRE (OTW) BALLOON DILATATION CATHETER

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 Class 2 Device Recall SPRINTER OVERTHEWIRE (OTW) BALLOON DILATATION CATHETERsee related information
Date Initiated by FirmJune 24, 2022
Create DateAugust 01, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1483-2022
Recall Event ID 90552
PMA NumberP790017S081 
Product Classification Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
ProductMedline 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 GTIN/UPN 00643169850491, Lot Number: 222066656 Expiration Date: 04/13/2023
FEI Number 3001504994
Recalling Firm/
Manufacturer		 Medtronic Inc
710 Medtronic Pkwy Mailstop Ls245
Minneapolis MN 55432-5603
For Additional Information ContactKrystin Hayward
763-514-4000
Manufacturer 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.
FDA Determined
Cause 2		Labeling Change Control
ActionThe 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.
Quantity in Commerce84 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LOX
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