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Medtronic Vascular, Inc. recalls NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic,
Recalled October 9, 2013 · FDA recall Z-2302-2013 · Medtronic Vascular
Hazard
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 Class II
Units
122
Sold at
Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
Description
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.
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.
Manufacturer(s)
Medtronic Vascular, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →