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# Sterilmed Recalls Introducer Sheath
- URL: https://www.fdaweb.com/sterilmed-recalls-introducer-sheath/
- Published: 2018-01-02T12:00:00.000Z
- Updated: 2026-09-14T23:09:33.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140385

Sterilmed has begun a Class 1 recall of its Reprocessed Agilis Steerable Introducer Sheath due to an improper seal of the sheath hub. “Improper seals can allow blood to leak through the hub, cause the cap to fall off during the procedure, or can create a difference in pressure that allows air into the circulatory system (air embolism),” a [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm590903.htm?ref=fdaweb.com) says. The sheath is used to insert and position various cardiovascular catheters in the heart, including on the left side of the heart through the wall of tissue that separates the right and left chambers of the heart (interatrial septum). “The improper seal occurs when not enough glue is used to reattach the cap to the hub after reprocessing,” the notice says. Too much glue can also block the sheath valve and make the device unusable.