Roche Accu-Chek FlexLink Plus Infusion Set Recall Issued

Roche is recalling the ACCU-CHEK FlexLink Plus infusion set, one of its newest insulin delivery systems, due to a defective design that could prevent patients from receiving the correct amount of medication. 

The ACCU-CHEK FlexLink Plus infusion set recall was announced this week by the FDA and Roche after the company determined that the infusion set could under deliver insulin due to a cannula that can become bent during insertion.

If too little insulin is delivered by the Roche Accu-Chek FlexLink Plus infusion set, this could cause patients to experience elevated blood glucose levels, cause hyperglycemia and potentially lead to serious or fatal injury. According to Roche, no injuries or illnesses have been reported in connection to the defective infusion sets.

Untreated hyperglycemia can lead to Diabetic Ketoacidosis (DKA), serious illness and death. Symptoms of hyperglycemia can include abdominal pain, blurred vision, excessive thirst or hunger, frequent urination, fruity acetone breath, fatigue, headache and nausea/vomiting.

The recall affects the ACCU-CHEK FlexLink Plus infusion set that was launched in November 2010. Other ACCU-CHEK infusion sets are unaffected.

Roche Insulin Delivery Systems is advising customers to stop using the FlexLink Plus, contact their health care providers and contact the company to receive an alternative infusion set. Roche announced that the FlexLink Plus will not be available again until they have fixed the problem.

In July 2009, a similar recall was issued for Medtronic Quick-Set infusion sets for its MiniMed Paradigm insulin pumps. The Medtronic Quick-set infusion sets were found to have a manufacturing defect that could result in the delivery of incorrect doses of insulin, and a number of people have reported on this site about experiencing serious diabetic injuries as a result of the infusion set problems.