ACCU-CHEK FlexxLink Plus infusion sets designed to deliver insulin to diabetic patients are being recalled by the manufacturer, Roche Insulin Delivery Systems, because of the cannula, or delivery tubing, can bend or kink, creating a potential for under-delivery of insulin. If this problem remains unnoticed, it can result in too little or even no insulin delivered into the bloodstream, which could cause elevated blood glucose levels, also known as hyperglycemia.

This recall is listed as a Class 1, the most serious type of recall the Food and Drug Administration (FDA) can issue and involves situations in which there is a reasonable probability that use of the products will cause serious adverse health consequences or death.

The symptoms of hyperglycemia include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath and abdominal pain. If untreated hyperglycemia could lead to Diabetic Ketoacidosis (DKA), serious illnesses and, in severe cases, death. Patients experiencing these symptoms are advised to check their blood glucose to ensure that the blood glucose level is within an acceptable range as defined by the patient’s healthcare team and to follow the medical advice given by the their healthcare team or contact their physician.

Roche has advised all its customers to discontinue use of ACCU-CHEK FlexLink Plus infusion sets and to contact their doctors or caregivers to determine if any changes to their therapy needs to be made. Customers are also given the local ACCU-CHEK customer care number (800-688-4578) for support on obtaining alternative infusion sets, such as the ACCU-CHEK Tender or ACCU-CHEK Rapid-D infusion set. The ACCU-CHEK FlexLink Plus sets will not be available until the problem has been fixed.

The recall only applies to the ACCU-CHEK FlexLink Plus that was launched in November 2010. Use of the previous version, ACCU-CHEK Ultraflex, or other ACCU-CHEK infusion sets or insulin pumps are not affected by the recall.

Any side effects while using these devices should be reported to the Food and Drug Administration MedWatch Adverse Events Reporting Program at www.FDA.gov/MedWatch.