Huber Needle Recall: Coring Could Cause Injury, Death

Federal regulators have issued a Class 1 recall for Huber needles by Multi-Med, Inc., which could potentially core silicone slivers out of vascular access ports, causing severe injury or death to patients. 

The Huber needle recall was originally announced at the end of May, but this week the FDA declared the situation a Class 1 medical device recall and issued a safety alert to health care professionals. The Huber needles are safety needles that are used on vascular access ports implanted in patients who receive regular intravenous therapy. They were advertised as non-coring, meaning that they would not remove chunks of the silicone keeping the port closed when pushed through.

Twice in the past year the FDA has tested the needles, manufactured by Multi-Med, and found that they cored the access port 23% to 86% of the time. The coring can cause the access ports to leak blood, medication and other fluids, which was how hospital staff began first noticing the problem. However, the needles could also push slivers of silicone into the patients’ bodies, where they could cause infection, swelling, tissue damage, pulmonary embolism or death. The severity of possible injury has led the FDA to classify the Huber needle recall as Class 1, the most serious category of medical device recall.

The needle recall affects 22 Gauge x 1 inch straight Huber needles from Multi-Med, Inc. with a model number of 10600218 from Lot 9B020M, and 22 Gauge Right Angle x 1 inch Huber needles with a model number of 10600219 from Lot 9B017M. However, the needles were not sold individually, but were sold to Navilyst Medical Inc. and packaged with certain lots of Vaxcel Implantable Vascular Access Systems with and without PASV (Pressure Activated Safety Valve) Technology. Some of the Vaxcel systems may be labeled as being from Boston Scientific, since Navilyst bought Boston Scientific’s Oncology Division in 2008.

A complete list of the models and lot numbers of Vaxcel Access Systems affected by the recall is available in the FDA recall announcement.

The FDA is recommending that all medical institutions immediately examine their inventories, quarantine and discontinue use of the Huber needles provided with the Vaxcel systems.