April 14, 2009 - The voluntary medical device recall initiated on Feb. 2, 2009 by Arrow International’s Cardiac Care Division involves volume connectors for its 30cc, 40cc and 50cc Intra-aortic balloon pump (IABP) catheters as a class 1 recall.
The FDA defines class I recalls as, “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”
The recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device that is inflated to less than 2/3 full could also result in thrombus formation on the IABP and possible subsequent systemic or cerebral thromboembolism.
Instructions contained in the operator’s manual fully describe the necessary warnings and precautions that will identify the issue. The recall notice restates these instructions and references the sections in the owner’s manual. If these instructions are followed, the issue for which the product was recalled can be discovered immediately, and the product can be removed and replaced.
Arrow International notified both domestic and foreign hospitals and distributors via an urgent medical device recall letter dated Feb. 2, 2009 that the company had become aware that the blue connector for the 40cc IABP was not properly recognized by the Arrow IABP system. This recall involved the retrieval of unused product, issuance of mitigation instructions for patients and/or facilities in critical need, and the replacement of pump tubing assemblies.
The products affected are: 30/40/50 CC IAB Catheters, with product codes: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.
A list of products and lot numbers affected by this recall as well as the original recall notice can be found at Arrow’s website.
For more information: http://www.arrowintl.com/iab_recall.asp