Animas has identified a component issue affecting all lots of Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The Animas 2020 Insulin Pumps are used to deliver insulin directly into the blood for the treatment of diabetes. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:
- “Loss of prime”
- “No Cartridge detected”
If a user receives any of these alarms, the pump may prompt the user to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect the infusion set from the user’s body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing the user in danger of potential serious health risks, such as hypoglycemia.
Users should follow the safety instructions in the Animas Owner’s Booklet and always disconnect the infusion set from the body when rewinding the motor, loading the cartridge, or priming the infusion set.
The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a “Call Service Alarm.”
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall