Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath
MedSun: Newsletter #56, January 2011

FDA MedWatch Safety Alert

The Arrow Ultra 8 Intra-Aortic Balloon Catheters (IABS) 8 FR 30CC and 40CC Universal and Arrow Intra-Aortic Balloon (IAB) Catheter with a Fiber Optic Sensor and a Measurement System are recalled because the catheters can become stuck in the sheath. When the IAB catheter becomes stuck, the user is unable to move the IAB catheter forward or backward, causing delay in therapy, bleeding or arterial injury. Customers are advised to immediately discontinue use of any affected products.

Additional Information:

FDA MedWatch Safety Alert. Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath. December 29, 2010.
http://wcms.fda.gov/FDAgov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm238408.htm


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