FDA Issues Recall for Arrow International IAB Catheters

from <a href="https://theheart.org/" target="_blank">Heart<i>wire</i></a> &#151; a professional news service of WebMD

Disclosures

April 16, 2009

April 16, 2009 (Rockville, Maryland) — The FDA has issued a class 1 recall for a number of intra-aortic balloon pump (IAB) catheters manufactured by Teleflex's Arrow International because of a fault in the connector of the pump tubing assembly [1]. This announcement follows a voluntary urgent medical-device recall letter for the products issued by the company in February [2].

The IAB catheters are components in the Arrow intra-aortic balloon pump (IABP) system. Arrow said this week that there have been 25 complaints with regard to this issue, but no reports of patient injury so far [3].

The company said it became aware, through a small number of customers, that the blue connector for the 40-cc IAB was not properly recognized by the IABP system. It notified both domestic and foreign hospitals and distributors of the problem in its recall letter, dated February 2, 2009, as well as the FDA. The February 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 fault could 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. If the incorrect volume is pumped, poor or no augmentation support will result, reducing the therapeutic efficacy of the product and increasing the risk of ischemic events. This could, in turn, cause organ injury or infarct and possibly result in patient death, notes the FDA in its recall notice. Prolonged exposure could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

The affected products were manufactured from January 2008 through January 2009 and were distributed from January 2008 through January 23, 2009. A list of recalled models can be found in the FDA recall notice, with a link to affected lot numbers on the Arrow website.

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