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# Atrium Medical Recalls iCast Stent System
- URL: https://www.fdaweb.com/atrium-medical-recalls-icast-stent-system/
- Published: 2022-06-02T12:00:00.000Z
- Updated: 2026-09-14T17:47:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151961

Atrium Medical has recalled its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter hub separating from the delivery system when it is being removed from a patient. “This issue seems to occur most often when the stent system is used outside of the indications for use, for example to treat vascular conditions,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/atrium-medical-corporation-recalls-icast-covered-stent-potential-balloon-or-catheter-hub-separation?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. There have been 75 complaints, nine injuries, and no deaths related to this device issue.

“If a separation occurs and the balloon is not fully deflated before the device is removed from a person’s blood vessel, it may cause the procedure to take longer than expected, exposing the person to additional anesthesia and/or imaging chemicals known as contrast,” the notice says. The separated parts could also remain in the body after the delivery catheter is removed, which might lead to vascular occlusion and thus causing amputation, embolism, loss of organ function, organ infarction, or tissue infarction, it says.

The expandable balloon stent is intended to be delivered using a catheter to hold open and support structure walls within the body. It is currently indicated for use to hold open the airways (tracheobronchial stent).