Back in early January, Animas Corporation issued a recall notice to customers in possession of its Animas® 2020 Insulin Pump. It seems the company had identified two problems with its device. Now the FDA has issued a Class I recall notice, its most serious type of recall and reserved for cases where human health is at risk by continued use of the device.
Animas Corporation is a division of Johnson and Johnson, for whom this will be a drop in the ocean of bad news at the present time. The product problem is twofold: Firstly a component issue impacting a small supply of the Animas® 2020 insulin pumps means that they may be prone to issuing false alarms. While these are “false”, unless users follow the pump’s safety instructions and disconnect the infusion set from the body during the “rewind, load and prime” steps, this can lead to unintended delivery of insulin, placing the patient in danger of potential serious health risks.
The second issue is a software limitation affecting the Animas® 2020 insulin pump that will impact its ability to function after December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a Call Service Alarm.
For these two reasons the company is recalling and replacing the affected devices which are identified as all lots manufactured from March 1, 2012 to November 30, 2012.
Find the FDA recall notice here.