Arrow NextStep Catheter Recall Issued After Reports of Breakage

A recall has been issued for six lots of Arrow NextStep antegrade chronic hemodialysis catheters, after multiple complaints surfaced of the units breaking and of the stylets separating, which could result in serious or potentially life-threatening injury

The FDA announced the Arrow catheter recall on June 28, after the manufacturer, Arrow International, Inc. sent a letter to its customers to quarantine the units.

Arrow NextStep Antegrade Catheters are designed for long-term use in patients who are undergoing hemodialysis or apheresis. They are typically placed into the large vein of the patient’s neck. Arrow has received reports of the catheters breaking and separation of the stylet within the catheters.

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The FDA has classified the action as a Class 1 medical device recall, the most serious type of medical device recall. The classification means that the FDA believes there is a reasonable probability that these catheters will cause serious adverse health consequences or death.

The catheter recall affects Arrow International, Inc. Arrow NextStep Antegrade Chromic Hemodialysis Catheters manufactured between April 14, 2011, and May 9, 2011. The recall affects six lots, including lot RV1034909, with product number CS-15192-IXM; lot RV1034911, with product number CS-15232-IXM; lot RV1034912, with product number CS-15272; lot RV1034913, with product number CS-15312-IXM; lot RV1034914, with product number CS-15422-IX; and lot RV1034915, with product number CS-15502-IX. Catheters affected by the recall were shipped to health care facilities and health care professionals in California, Delaware, Florida, Michigan, North Carolina and Tennessee.

Arrow has already sent an “Urgent Medical Device Recall” letter to registered customers. The hospitals and medical providers have been asked to check their inventory for affected products, stop using them and quarantine the devices. Customers with questions can contact Arrow International, Inc. Customer Service at 1-800-233-3187.

This is the second Arrow catheter recall in less than a year. In December 2010, an Arrow IAB catheter recall was announced after the company and FDA received reports of the catheters getting stuck in their sheaths. The IAB catheters were used to treat heart failure, heart attacks and septic shock and are often used to stabilize high-risk patients.

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