Class I Recall of Arrow Intra Aortic Balloon Pump (IAB) Catheters

Teleflex Medical and FDA notified have issued a Class 1 recall for Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters, a component of the Intra-Aortic Pump System which is designed to provide cardiac assist therapy to critically ill people to increase blood flow to the heart.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump to default to 2.5 ccs or 5 ccs (depending on the Intra-Aortic Balloon Pump model) rather than the appropriate 30, 40, or 50 cc volume. This could in turn result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

The recalled models include:

8 Fr 30cc Narrow Flex IAB Catheter Kit, Product Number: IAB-04830-U
8 Fr 40cc Narrow Flex IAB Catheter Kit, Product Number: IAB-04840-U
8 Fr 30cc Ultra 8 IAB, Product Number: IAB-05830-U
8 Fr 40cc Ultra 9 IAB, Product Number: IAB-05840-U
7.5 Fr 30cc UltraFlex IAB, Product Number: IAB-06830-U
7.5 Fr 40cc UltraFlex IAB, Product Number: IAB-06840-U
8 Fr 30cc FIBEROPTIX IAB, Product Number: IAB-05830-LWS
8 Fr 40cc FIBEROPTIX IAB, Product Number: IAB-05840-LWS
7 Fr 30cc Rediguard IAB, Product Number: IAB-S730C
8 Fr 40cc Rediguard IAB, Product Number: IAB-S840C
9 Fr 50cc Rediguard IAB, Product Number: IAB-R950-U
ARROW 40cc Drive Line Kits, Product Number: IAK-02692
ARROW 50cc Drive Line Kits, Product Number: IAK-02693

These products were manufactured from January, 2008 through January, 2009 and were distributed from January, 2008 through January 23, 2009.

APRIL-15-09: Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters [FDA: CLASS 1 RECALL: TELEFLEX MEDICAL, ARROW INTERNATIONAL 30,40, AND 50 CC INTRA-AORTIC BALLOONS]

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Published on Apr-15-09