Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall - Catheter Tip Can Break Inside of the Patient
MedSun: Newsletter #62, July 2011

FDA MedWatch Safety Alert

The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery. Boston Scientific Corporation notified customers by letter on May 27, 2011 describing the problem, the potential hazard, and the action to be taken. Customers were instructed to discontinue use and return all products to Boston Scientific.

Additional Information:

FDA MedWatch Safety Alert. Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient. June 14, 2011.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259097.htm


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