Animas Insulin Infusion Pump Recall Issued Due to False Alarm, Warnings

A Class I recall has been issued for specific Animas insulin infusion pumps, due to a risk that a component in the pump may trigger a false alarm or warning, prompting the user to initiate a reset process that can be dangerous if not completed properly. 

An Animas 2020 Infusion Insulin Pump recall was initially issued on January 3, but it was re-announced on April 4, after the manufacturer noticed a component in the pump may trigger a warning related to “loss of prime”, “occlusion”, “no cartridge detected”.

The insulin infusion pump problems pose a potential hazard for users, as it will prompt the user to run a complete “rewind, load and prime” process and if the pump is not detached from the user during this reset, an unintended amount of insulin may be administered to the user, posing serious health risks and even death.

Did You Know?

AT&T Data Breach Impacts Millions of Customers

More than 73 million customers of AT&T may have had their names, addresses, phone numbers, Social Security numbers and other information released on the dark web due to a massive AT&T data breach. Lawsuits are being pursued to obtain financial compensation.

Learn More

Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012 are impacted by the recall. The pumps are equipped with a software limitation that only allows the pump to run until December 31, 2015. After this date the device will display a “Call Service Alarm”.

The FDA has designated the action as a Class I recall, which suggests that continued use of the product poses a serious risk of severe adverse health consequences or death.

The manufacturer advises consumers with the recalled Animas insulin pumps to carefully follow the rewind, load and prime process by detaching the machine from their body when the pump alarms. Consumers should also contact Animas’ Product Fulfillment Center at (877) 280-2339 to schedule a free shipping of a replacement pump. Users are also encouraged to report any adverse events to FDA’s MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online at www.fda.gov/MedWatch/report.htm or call 1-800-332-1088 to request the reporting form.

0 Comments

Share Your Comments

I authorize the above comments be posted on this page*

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

This field is for validation purposes and should be left unchanged.

More Top Stories

Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery
Uber Driver Sexual Assaults and Misconduct Reports Must Be Disclosed in Lawsuit Discovery (Posted today)

A federal magistrate judge is forcing Uber to hand over potentially hundreds of thousands of incident files involving reports of passengers who suffered sexual misconduct or sexual assault at the hands of the rideshare service's drivers.

Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits
Abbott May Remove Infant Formula for Preemies Off the Market Due to Similac NEC Lawsuits (Posted yesterday)

Abbott Laboratories is considering removing Similac infant formula products designed for preterm babies from the market, as it faces hundreds of lawsuits claiming the products increase the risk of necrotizing enterocolitis, which puts newborns at a high risk of permanent injuries and death.

Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL
Information About Suboxone Dental Claims To Be Exchanged By Parties in MDL (Posted 2 days ago)

A federal judge has ordered parties involved in Suboxone dental decay lawsuits to submit proposals for exchanging information that will guide the selection of representative bellwether claims for early test trials.