The medical device firm Medtronic, based in Dublin, is temporarily recalling definite lots of its MiniMed infusion sets utilized through all form of its insulin pumps around the globe, comprising 5,000 sets from India. The recalls are associated with a component issue that could low down the blood sugar level in patients, as per the company.
The infusion sets of Medtronics are used to deliver insulin through the pump to the patient suffering from diabetes. The set includes a tubing connector, disposable tube, and cannula, which is inserted in the abdominal area through the skin.
As per the spokesperson, the infusion sets were among lots that were launched in early 2000. Approximately, 90% of the recalled sets from India are swapped at the distributor’s facility. The medical device manufacturer has ample of replacements for infusion sets to provide the customers who need them on priority.
According to the spokesperson, 4,000 patients utilize insulin pump made by Medtronic in India.
The company identified that it has been identified that a component called vent membrane in the recalled infusion might be vulnerable to blockage caused by fluid in the process of fill-tubing or priming. Thus, it can lead to the possibility of over dose after the change of infusion set, causing hypoglycemia.
The company has communicated the issue to the Food and Drug Administration (FDA) and other regulatory bodies in various countries about the recall.
The spokesperson stated that it is intricate to project as of how many are new recalled infusion sets are in the hands of the customer that needs to be replaced. The patients can have glance at the lots’ characteristics of their infusion sets through an online tool, which will ease the procedure to exchange the problematic infusion sets into new one.
The authorized person claimed that about 10% infusion sets of Medtronic in this lot will be recalled around the globe.
The newly produced infusion sets comprises a design revision of this component that might lessen the risk of the insulin over deliver after switching the infusion set.
This temporary recall is not projected to affect the revenue growth of the company’s Diabetes Group in the Q2 or the full financial year. The Diabetes Group of Medtronics, in the previous year, achieved the net sales figure of $1.8 Billion global in the fiscal year 2016.
Thus, the company with this recall will aid various patients by creating awareness and preventing the usage of the likely defective infusion sets.