The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death
- All OmniPod Insulin Management Systems manufactured from July 2015 to August 2015
- All affected lot codes.
- Distribution Dates: 09/2015 To 09/2015
- Devices Recalled in the U.S.: 26,230 boxes Nationwide
The OmnniPod Insulin Management System is an insulin pump used to deliver insulin to people with diabetes. The insulin pump is a small adhesive “Pod” that sticks directly on the body. Insulin is delivered through a small port holding a tube that is inserted into the skin.
Reason for Recall
The Pod's needle mechanism may fail or delay in inserting the needle. If the needle mechanism fails or there is a delay, the needle will not be inserted in the patient's skin and insulin delivery will not begin.
The interruption of insulin delivery may lead to high blood sugar (hyperglycemia). If left untreated, hyperglycemia can cause life-threatening conditions or even death.
The firm has received 10 cases where the malfunction occurred. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
Who May be Affected
All patients using the OmnniPod Insulin Management System with the affected lot codes
What to Do
Insulet notified customers of this issue on November 2, 2015.
Consumers who have Pods from the affected lots should ensure the needle mechanism has deployed properly. If a patient has activated a Pod and experiences unexpected elevated blood glucose levels, a health care professional should be consulted.
Customers should call Insulet Customer Care by calling 1-855-407-3729, 24 hours a day, 7 days a week.
Date Recall Initiated
November 2, 2015
- Firm Press Release: Insulet Corporation Issues Field Safety Notification of OmniPod Insulin Management System (December 1, 2015)
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.