Glidesheath Slender® Introducer Sheath

Through post-market surveillance, we have received complaints for the guidewire not being able to pass through the needle. Through our investigation it was determined that a portion of the lot had the incorrect guidewire size. Terumo has received 84 complaints for this issue and no serious injuries. The probability of medically reversible or transient adverse health consequences is not likely. The situation is detectable at the time of use. There is no risk to patients who have used this lot. 1. Review your Glidesheath Slender inventory and immediately isolate lot number 0001441871.