Atrium recalls iCast Stent for separation risk that may cause harm

Serious injuries or death may result from the use of these devices. This is a Class I recall, the most serious type of recall.

If your email program has trouble displaying this email, view as a webpage. 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. Read More Questions? Customers with questions or concerns about this recall should contact Atrium Medical Corporation at 603-880-1433.

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