Z-2302-2013Class II

NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer...

Name: Z-2302-2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer...
Creator: Medtronic Vascular, Inc.
Published: 2013-09-16
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-09-16 / Terminated

FDA source

Medtronic Vascular, Inc. began a recall of NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis... on 2013-09-16. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2302-2013
Classification: Class II
Status: Terminated
Initiated: 2013-09-16
Posted: 2013-09-30
Terminated: 2014-02-10
Recalling firm: Medtronic, Inc.
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.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
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 root 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.
Product codes and lots: Lot number 207002011; Exp 5-13-2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2302-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2302-2013	Class II	Terminated	Voluntary: Firm initiated	2013-10-09	2013-09-30

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)