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Boston Scientific Corporation recalls Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a
Recalled August 15, 2018 · FDA recall Z-2735-2018 · Boston Scientific
Hazard
Potential polymer material degradation. · FDA Class II
Units
31,005
Sold at
Worldwide - US Nationwide Distribution - AL, FL, IL, IN, KY, MA, MI, MN, MS, NC, NV, NY, OH, OR, TN, TX, UT, WA and the country CANADA
Description
Potential polymer material degradation.
Product
Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire reinforcement within the wall for torque transmission and strength, and polymer materials along the length of the catheter for support and flexibility. The catheter has an atraumatic tip and a hub/strain relief combination for kink resistance (at the hub), device connectivity, and device handling.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →