Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
NC Sprinter Recalled by Medtronic Vascular, Inc. Due to Compliance chart included in lot 207002011 of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Vascular, Inc. directly.
Affected Products
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.
Quantity: 122
Why Was This Recalled?
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.
Where Was This Sold?
Worldwide Distribution - USA and the countries of Australia, Belgium, Canada, Hong Kong, Malaysia, New Zealand, Singapore, Spain, Switzerland, Taiwan and Thailand.
About Medtronic Vascular, Inc.
Medtronic Vascular, Inc. has 19 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report