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ev3 Inc. recalls Pacific Xtreme (PTCA Balloon Dilation Catheter)
Recalled October 7, 2020 · FDA recall Z-3055-2020 · ev3
Hazard
Labeling discrepancy for the Rated Burst Pressure (RBP) value. · FDA Class II
Units
4286 devices
Sold at
Domestic Distribution: AL, AR, AZ, CA, CO, DC, DE, FL, GA, IA, IL,IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX,VA, WA, WI and WV. International Distribution: Canada and Puerto Rico.
Description
Labeling discrepancy for the Rated Burst Pressure (RBP) value.
Product
Pacific Xtreme (PTCA Balloon Dilation Catheter)
Manufacturer(s)
ev3 Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →