Atrium recalls iCast Stent for separation risk that may cause harm

U.S. Food and Drug Administration sent this bulletin at 06/02/2022 11:37 AM EDT

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CDRH Medical Device Recall

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Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

Atrium Medical Corporation is recalling the iCast Covered Stent System after receiving increased customer complaints about the separation of the balloon or catheter hub from the delivery system when the delivery system is removed from a person. If this occurs, it may cause serious harm.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.

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Questions?

Customers with questions or concerns about this recall should contact Atrium Medical Corporation at 603-880-1433.