NC Sprinter — Class II medical device recall Z-2302-2013
Terminated recall by Medtronic Vascular, Inc., reported 2013-10-09. Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the d
| Recall number | Z-2302-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2013-09-16 |
| Classified | 2013-09-30 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2014-02-10 |
| Countries outside the US | AU, BE, CA, CH, ES, HK, MY, NZ, SG, TH, TW |
| Quantity | 122 |
| Lot numbers | 207002011 |
| Model numbers | NCSP22512X |
| Expiration dates | 2015-05-13 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2302-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.