Class 2 Device Recall NC Sprinter; Rapid Exchange Balloon Dilatation Catheter

• Date Initiated by Firm: September 16, 2013
• Date Posted: September 30, 2013
• Recall Status: Terminated on February 10, 2014
• Recall Number: Z-2302-2013
• Recall Event ID: 66334
• PMA Number: P790017S095
• Product Classification: Catheters, transluminal coronary angioplasty - Product Code LOX
• Product: NC Sprinter; Rapid Exchange Balloon Dilatation Catheter;; Sterile; 2.25 mm; Model NCSP22512X.; Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432; ; The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place.
• Code Information: Lot number 207002011; Exp 5-13-2015.
• Recalling Firm/ Manufacturer: Medtronic Vascular, Inc.; 3576 Unocal Pl; Santa Rosa CA 95403-1774
• For Additional Information Contact: Carlos Alfonzo; 763-526-2513
• Manufacturer Reason for Recall: Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Medtronic sent an Urgent Medical Device Recall letter beginning September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Our records indicate that your facility has received affected NC Sprinter RX Balloon Dilatation Catheters as noted in the attached customer notification detail report. Consequently, Medtronic is asking you to take the following actions: 1. Remove and quarantine all affected catheters that remain in your inventory. 2. Return the affected catheters to Medtronic. A Medtronic representative can assist in facilitating the return and replacement of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. Medtronic has taken the necessary steps to prevent any future shipment of mislabeled product. Regulatory agencies will be notified about this recall as applicable. Please share this notification with others in your organization as appropriate. If any NC Sprinter RX Balloon Dilatation Catheters within the scope of this recall have been forwarded to another facility, please notify that facility accordingly and facilitate the retrieval of the affected product. We appreciate your cooperation and apologize for the inconvenience that this issue may cause. Should you have any questions, please contact your local Medtronic representative.
• Quantity in Commerce: 122
• Distribution: Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
• Total Product Life Cycle: TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LOX and Original Applicant = MEDTRONIC IRELAND