Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2302-2013 — 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 Exch

U.S. FDA — Device Enforcement · United States · 2013-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2302-2013
Date of alert: 2013-09-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Vascular, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 207002011

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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