In a year that has seen a multitude of medical device recalls, Unomedical is the latest company to land a Class I tag after issues with its Varisoft infusion sets.
The devices are used with insulin pumps made by US-based Tandem Diabetes to deliver the hormone subcutaneously to patients with diabetes. An issue during the manufacturing of Unomedical’s infusion set means the connector may detach. This can result in a disruption of insulin delivery from the pump, according to an alert from the US Food and Drug Administration (FDA).
The Class I tag by the FDA indicates that the defect may cause serious injury or death – only one injury has been reported so far.
Around 13,000 boxes of the devices – each with ten sets – have been recalled in the US. Denmark-headquartered Unomedical initiated the recall in October 2023.
The damage to the connector affects eight batches of lot numbers manufactured between April and August 2022.
The FDA said that if the connector detached during sleep or in instances not recognisable by the patient, it could lead to hyperglycaemia. Insulin would instead flow through the disconnected tubing and the pump would detect the problem.
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The infusion sets offer patients with limited potential insertion sites or scar tissue more flexibility by offering a larger insertion angle compared to traditional needles or cannulas.
After Unomedical sent Tandem an urgent field safety notice last month, the pump maker notified customers to stop using the sets and said it would facilitate a return of the devices.
There have been a high number of medical device recalls in 2023. Many have been tagged as Class I – the most serious type of recall – by the FDA. A report by Sedgwick stated recalls have reached a four-year high and pointed to manufacturing defects as a leading factor of the heightened recall levels.
There have been high-profile cases of companies navigating diabetes device issues this year. Insulet reported a data breach affecting 29,000 of its insulin pump users. Meanwhile, Abbott was issued a warning from the FDA in April over fears the company’s glucose monitors could catch fire.
Medtech giant Medtronic has been subject to multiple lawsuits concerning failures of its MiniMed insulin pumps. These faced multiple recalls in the past decade and may have caused more than 2,000 injuries and one death.