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Cordis US Corp recalls PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG399
Recalled July 20, 2022 · FDA recall Z-1363-2022 · Cordis US
Hazard
Potential for stent dislodgement and associated failures related to two specific sizes of the device. · FDA Class II
Units
1,089 units
Sold at
US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, and WY. There was also government/military distribution.
Description
Potential for stent dislodgement and associated failures related to two specific sizes of the device.
Product
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX.
Manufacturer(s)
Cordis US Corp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →