Arrow IAB Catheter Recall Issued Due to Defective Sheaths
A risk of bleeding and arterial injury due to defective sheaths has led to a Class I recall of Arrow intra-aortic balloon (IAB) catheters.
The Arrow IAB catheter recall was announced on Wednesday by the FDA, which declared it a Class I medical device recall because the defective catheters are likely to cause severe injury or death. The recall was announced after it was determined that the catheters can become stuck in their sheath, making the user unable to move the catheter forward or backwards.
The IAB catheters are used to treat heart problems including heart failure, heart attacks, and septic shock. They are often used in stabilizing high-risk patients during non-surgical and diagnostic procedures.
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On December 21, Arrow International Inc. sent out a letter to customers warning that it had received an increasing number of “stuck in sheath” complaints about the catheters. The defect could delay critical therapy, the company warned. The company also noted that excessive manipulation of a stuck IAB catheter could cause excessive bleeding, arterial damage, significant vasospasm, prolonged tissue ischemia, injury, heart attack or death. No injuries or illnesses were reported in connection to the IAB catheter defects.
The recall affects the Arrow Ultra 8 Intra-Aortic Balloon 8 FR 30CC and 40CC Universal Catheters and the Arrow Intra-Aortic Balloon Catheters with a Fiber Optic Sensor and Measurement System. The recalled devices have the model numbers IAB-05830-U, IAB-05840-U, IAB-05830-LWS, and IAB-05840-LWS. The devices were manufactured from January 2009 through October 2010 and were distributed from November 2009 through October 2010.
Arrow International sent detailed instructions to customers on how to send back the affected devices in order to receive a replacement to health care facilities and customers who had purchased the catheters. The company also offered to credit the accounts of those who returned the products but did not want a replacement. The company warned that there may be limited availability for replacement products.
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