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All product recalls associated with AngioScore Inc..
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Dec 2009
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Separations of the PTCA catheter shaft at the guide wire exit port have occurred during treatment of coronary artery stenosis. Fragments of the catheter may become lodged in coronary arteries, which resulting in serious patient outcome and require emergency coronary bypass surgery and medical intervention to remove the retained device fragments.
Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton