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Arrow struck with Class I recall notice from FDA

This article was originally published in Clinica

Executive Summary

Arrow International’s recall of its intra-aortic balloon catheters has been given the most severe type of warning from the US FDA. In October, Arrow warned customers that products among certain lots of its intra-aortic balloon catheter technology could become stuck in their sheaths and not be able to move forward or backwards, potentially causing a delay in therapy, bleeding, or even arterial injury. The recall, which now has been handed a Class I notification by the FDA, also includes Arrow’s intra-aortic balloons. Arrow, an Everett, Massachusetts-based subsidiary of Teleflex Medical, distributed the faulty products from November 2009 until October 2010 but is now urging customers to discontinue use of the malfunctioning devices. The catheters and balloons are used to treat heart failure, septic shock and myocardial infarction.

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