Some of the pods may have a higher rate of failure than the company's manufacturing standards
of ConsumerAffairs
Insulet Corporation is recalling 40,846 boxes (ten pods per box) of the OmniPod (pod) Insulin Management System.
Some of the pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. The OmniPod Personal Diabetes Manager (PDM) is not affected.
The affected pod lots have resulted in 90 Medical Device Reports of which 13 required medical intervention. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots.
There are two ways in which these pods can fail at a rate that is higher than Insulet's current standard. The cannula may either completely retract or fail to fully deploy, which may result in the patient not receiving the expected insulin dose.
Or the pod may trigger an audible alarm indicating it will no longer deliver insulin and will need to be replaced. Both situations can result in the interruption of insulin delivery that can cause hyperglycemia, which, if left untreated, can result in diabetic ketoacidosis (DKA).
The following OmniPod lots are being recalled:
| Distribution | Catalog Number | Description | Lot Number |
|---|---|---|---|
| United States | POD-ZXP420 | OmniPod® Insulin Management System | L40806 L40811 L40895 L40976 L41014 L41025 L41067 L41162 L41171 L41197 L41198 L41250 |
| International | 14810 | OmniPod® Insulin Management System | L40771 L40892 L40901 L40905 L40997 L41199 L41208 |
The lot number is located on the pod tray lid label and is also laser etched on the side of each individual pod. The lot number is also located on the box of OmniPods.
Customers who have pods from the affected lots should stop using them and return the pods for replacement.
The recalled products were distributed to customers from December 2013, to March 2015.
Distributors and customers have been notified by email, FedEx, and phone calls. The company is arranging for return and replacement of all recalled product.
Consumers with questions may contact the company at 1-855-407-3729 at any time.