FDA-Device2014-09-03Class II
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Cordis Corporation
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.
Sold states
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.
Affected count
250,000 units
Manufactured in
14201 Nw 60th Ave, N/A, Miami Lakes, FL, United States
Products
Cordis EMPIRA NC RX PTCA Dilatation Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2556-2014Don't want to check this manually?
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