Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"
Reason for recall: Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire" Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of BR, PL, SK, IT, DK, DE, GB, AT, KW, CR, ES, NL, LV, MT, IE, CH, ZA, RO, FI, PR, FR, CA, PA, IL, S Quantity: 233,817 Lot/code info: UDI-DI: 00845225002848, 00184360000037. Instructions for use: 300004875732_A Revision Date: 03/2021, 300004410212.A Release Date: 03/2021
00845225002848, 00184360000037, 300004410212
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.