Arrow catheters recalled after reports of sheath jamming

December 31, 2010

Limerick, PA - Arrow International is voluntarily recalling certain intra-aortic balloon (IAB) catheters because they can become stuck in their sheaths, possibly delaying therapy or leading to injury, the US Food and Drug Administration (FDA) announced yesterday [1].

The products under recall are:

  • Arrow Ultra 8 Flexible IAB Catheter 8 Fr 30 cc.

  • Arrow Ultra 8 Flexible IAB Catheter 8 Fr 40 cc.

  • Arrow FiberOptix IAB Catheter 8 Fr 30 cc.

  • Arrow FiberOptix IAB Catheter 8 Fr 40 cc.

The manufacturer, a division of Teleflex Medical, stated in a press release last week that there has been an increase in "stuck-in-sheath" reports regarding the catheters [2]. Excessive manipulation of a stuck IAB catheter to move it forward or backward may result in arterial damage, excessive bleeding, and other adverse events—possibly death.

The company is advising customers to stop using the products immediately and to contact customer service at 1-866-396-2111.

The FDA has classified the company's action as a class I recall, the most serious kind, when there is a reasonable probability that a product's use will cause serious adverse health consequences or death.More information about today's announcement, including model and lot numbers of recalled catheters, is available on the FDA website.

To report adverse events related to Arrow IAB catheters, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

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