Recall Z-2302-2013— Medtronic Vascular, Inc.

Class II FDA medical device recall by Medtronic Vascular, Inc., initiated 2013-09-16, terminated 2014-02-10. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

Medtronic Vascular, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-09-16

Terminated

2014-02-10

Firm location

Santa Rosa, CA, United States

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