Arrow International, Inc.'s Arrow IAB Catheter Recall Issued Due to Defective Sheaths

Published: Dec 30, 2010

FDA -- 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.

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