|Johnson & Johnson is recalling its Animas 2020 insulin pumps.--Courtesy of Animas|
Animas, Johnson & Johnson's ($JNJ) insulin pump unit, is recalling its 2020 devices, warning that a malfunction may lead to unintended insulin delivery and put patients at risk. The FDA has assigned its most-serious Class I tag to the recall, saying the problem could lead to serious injury or death.
The Animas 2020 pumps manufactured from March to November last year have a faulty component that can lead to errant alarms, the company said, and the devices prompt patients to rewind, load and prime them, which can trigger unwanted infusion and put users at risk for hypoglycemia. Furthermore, the pumps have a software glitch that will render them unusable come Dec. 31, 2015, Animas said.
The company didn't say whether it had received any adverse event reports related to the malfunction, and the FDA is asking customers to report any problems through its online MedWatch system.
Animas launched the recall in January, instructing customers to disconnect the device from their bodies before resetting it and immediately reach out to the company for a replacement pump. Animas has since discontinued the 2020 pump and is directing customers to adopt its latest model, the OneTouch Ping.
This is J&J's second diabetes-related recall in a month, after the company's LifeScan glucose monitor unit yanked millions of its OneTouch VerioIQ devices off the market, warning that the products are incapable of warning patients whose blood sugar soars to dangerous levels, resulting in at least one death.
- read the FDA's note