Teleflex Medical and FDA notified healthcare professionals of the Class 1 recall for Arrow International 30cc, 40cc and 50cc intra aortic balloon (IAB) pump catheters, a component of the intra-aortic pump system designed to provide cardiac assist therapy to increase blood flow to the heart.
The recall is being conducted because a fault in the connector of the pump tubing assembly may result in failure of the system to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death, according to the agency and the Teleflex. 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; and
- ARROW 50cc Drive Line Kits, Product Number: IAK-02693.
On February 6, 2009, the Research Triangle Park, N.C.-based 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 and provided directions to continue using the product with specific instructions.