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Cordis Corporation recalls Cordis EMPIRA NC RX PTCA Dilatation Catheter
Recalled September 3, 2014 · FDA recall Z-2556-2014 · Cordis
Hazard
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery. · FDA Class II
Units
250,000 units
Sold at
Worldwide Distribution - USA including Puerto Rico and the states of AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WY and Hawaii., and the countries of Argentina, Brazil, Canada, Chile, Colombia, Mexico, Panama and Venezuela.
Description
The balloon may exhibit resistance to the removal of the balloon cover. Weakening of the affected product in the region of the proximal balloon seal may occur when excessive force is applied to remove the balloon cover. This may lead to balloon burst, shaft separation or deflation difficulties, which could result in procedural delay, vessel trauma or surgery.
Product
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Manufacturer(s)
Cordis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →