Medtronic Vascular, Inc.: Medical Device Recall in 2013 - (Recall #: Z-2302-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 16, 2013

Date Posted: October 9, 2013

Recall Number: Z-2302-2013

Event ID: 66334

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.

Status: Terminated

Product Quantity: 122

Code Information:

Lot number 207002011; Exp 5-13-2015.

Distribution Pattern:

Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.

Voluntary or Mandated:

Voluntary: Firm initiated