A recall of Intra-Aortic Balloon Pump Catheters issued by Arrow International in February has been deemed a Class I recall by the Food & Drug Administration (FDA). A Class I recall is the FDA’s most serious recall action, and indicates that a device poses a reasonable probability of serious injury or death to patients.
Intra-Aortic Balloon Pump Catheters are 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. According to the FDA, the Intra-Aortic Balloon Pump Catheters are being recalled because they may contain defective volume connectors. This defect 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. Prolonged exposure to the reduced flow of medication can lead to deadly organ failure in patients, the FDA said.
According to the recall notice, there have been 25 complaints about the problem associated with the faulty catheter connectors. No reports of patient injuries have been received.
The recall involves Intra-Aortic Balloon Pump Catheters in 30, 40, and 50 cc sizes of the following models:
* 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
The recall affects about 45,000 devices sold in 423 lots. These products were manufactured from January, 2008 through January, 2009 and were distributed from January, 2008 through January 23, 2009. The recall affects about 45,000 devices sold in 423 lots. A full list of the recalled lots can be found here.
On February 6, 2009, the company sent their distributors and customers a recall letter by certified mail to inform users about the problem. Users were:
* instructed to return the recalled products
* provided directions to continue using the product with specific instructions
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